Product risk management report

KH/JS-CE-QXB03 A/0

Risk Management Report of Surgical instruments

1 Introduction In accordance with MDD (93/42/EEC) requires, in accordance with the "risk management applications for medical devices", analyzed the clinical use of our products in the hazards that may exist, and the production of each hazard was determined. For each hazard to the severity of damage and harm the probability of occurrence was estimated. In a risk is unacceptable, to take control measures to reduce risk, while taking the risk of residual risk after control measures were evaluated. Finally, all the residual risks to an acceptable level, to ensure safe and effective products on the market. 2 Scopes The Company's surgical instruments with CE mark products. 3 application data 3.1 Application Standards ISO 14971 Medical Device Risk Management applications for medical devices ISO 7153-1 Surgical instruments - Metallic Materials Part 1: Stainless steel ISO / TR 14283 Implants for surgery - basic principles ISO 14630 Non-active surgical implants - General requirements ISO 15730 for the stainless steel finishing, polishing and passivation of metals and other inorganic coatings ASTM A 380 stainless steel parts of the standard criteria for removal and cleaning Stainless steel ASTM A 967 Standard Specification for Chemical Passivation ASTM D4169 transport container system performance test standard operating procedures 3.2 Application Information - "AO principles of fracture treatment, " translated Rong Dai Shike - "Study orthopedic surgery, " Zuber pass, Dai Jung Shike - "Clinical Orthopaedics Anatomy, " edited by GUO Shi Fu - "Clinical Orthopaedics" Li Shimin, editor of the party farming-cho - "Modern Orthopaedics" Zhao Dinglin Editor - "Emergency Orthopedics limb part of the " original ROBERT R. SIMON, STEVENJ.KOENIGSKNECHT Main translation Xiao Deming - "Fracture biomechanics Therapy, " Shu-Hui, Wang Xinhua, Du Maoxin editor - "Bone and bone surgical diagnosis and treatment of medical school, " Cao Jianzhong Hu Guangzhou, Zhang Dayong, Chang Hong Editor - "bone and joint diseases, " Zhang Shiqing, Wang, Ji Asia and Africa, edited by Liu - "Human Anatomy" Gu Xiaosong Editor Chapter total 20pages page1

Product risk management report

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4 the team of risk analysis Name Wang zhi ming Position/Responsibility Vice general manager, supervise production & technique department Technique adviser Manager of Technique Department Standardization Engineer Manager of Quality Department Manager of Logistic Department Marketing Manager Sales Manager Attending physician Duty Team Leader

Jiang de cheng Ma hao ming Yin zhuo Jiang qing xing Cao hua Wu zheng qian Wang tong Huang fei peng Xu li 5 Product Descriptions

Team Member Team Member Team Member Team Member Team Member Team Member Team Member Team Member Team Member

5.1 Overview The object of risk management involves surgical instruments. The company provides the surgical instruments is an essential tool for orthopedic surgery, orthopedic implants all products are required to meet the appropriate surgical instruments to properly install and reliably fixed to the patient's body, the safety of implantable devices also remove the need to use The appropriate surgical instruments. The production of surgical instruments with a variety of materials, such as: stainless steel, titanium, aluminum and non-metallic materials. Human exposure to traumatic surgical instruments, required hardness, toughness is moderate, leaving debris and difficult to oxidative corrosion, and have some biocompatibility. 5.2 Function Surgical instruments is a tool for orthopedic surgery. Purpose is to ensure safe and smooth implants implanted or removed. 5.3 use of the environment Surgical instruments available to medical institutions, the need for treatment of qualified and experienced doctors during the surgery. 6 The implementation of risk management process It is recognized that the concept of risk has two components: - the probability of occurrence of the damage, ie: how the recurrent occurrence of the Chapter total 20pages page2

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damage; - the consequences of harm, that is: how serious it is. Now according to the requirements of ISO14971, the two parts of surgical instruments for risk assessment and management products. 6.1 The intended purpose and qualitative and quantitative characteristics of the decision Appendix C of the Company pursuant to the requirements of ISO14971, for surgical instruments that may affect the security features of the problem of determining the following table: Table 1 the characteristic problem of determining the safety
Serial Number C.2.1 1.1 Determines Whether or not affects

What is the intended use and how to use?

Expected use of product Surgical instruments are essential tools for orthopedic surgery, adjuvant complete the operation. The Company's surgical instruments products from orthopedic doctor according to the type of surgery, choose the appropriate surgery for patients with surgical instruments.

1.2

How to use medical device

What is the role of Medical

1.3

1.4

1.5

devices in the diagnosis, prevention, care, treatment or mitigation, trauma and Not applicable disability compensation, replacement or correction of anatomy, etc. What is the indication (e.g. patients who need Orthopedic surgery patient population)? Whether to maintain or Not applicable support medical equipment life?

Continued Table 1 The characteristic problem of determining the safety Serial Number 1.6 Determines In the case of failure of medical devices need special intervention? Implantable medical devices are expected to be used? Medical equipments are Whether or not affects

Not applicable

C.2.2 C.2.3

Not applicable Applicable. Part of the surgical instruments during

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Product risk management report

expected to and contact with patients or other staff? In the medical device which contains materials and (or) components, or for sharing, or access to medical devices? Have the energy to give patients access to or from the body? Are there materials available to the patients or from patients? Whether the medical devices with biological material and then re-use, injection or transplant? Medical care is provided in the form or preparing a sterile sterilized by the user, or other method of sterilization of microbial control? Medical devices are expected by the routine cleaning and disinfection of the user? Medical equipment are expected to improve the patient's environment? Whether the medical device to measure? Whether the analysis and processing of medical devices? Medical equipment are expected, and other medical devices, drugs or other medical techniques used in combination? Is there no hope for energy or material output? Medical devices are sensitive to the environmental impact? Medical devices affect the environment? Are there basic supplies medical equipment or accessories The need for maintenance and calibration?

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surgery when necessary, contact with patients.

C.2.4

Applicable. The company's products, its biological properties and mechanical properties were already recognized by the medical profession.

C.2.5

Not applicable

C.2.6

Not applicable

C.2.7

Not applicable

C.2.8

Not applicable

C.2.9

Applicable. The company's products in the form of non-sterile products for use by the user (installer) for cleaning and disinfection. Not applicable

C.2.10

C.2.11 C.2.12

Applicable. Part of the caliper, sounding device with measuring function

Not applicable

C.2.13

Not applicable

C.2.14 C.2.15 C.2.16 C.2.17

Not applicable Not applicable Not applicable Not applicable

C.2.18

Use. Repeated use of the products after use to be maintained.

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C.2.19 C.2.20 C.2.21 Medical software? devices have Not applicable Not applicable Not applicable

KH/JS-CE-QXB03 A/0

Medical devices have limited storage life? For delayed and (or) long-term use effects? What kind of medical equipment to withstand mechanical forces? What determines the life of medical devices? Single-use medical devices are expected? The need for safety of medical devices out of operation or disposal?

C.2.22

Not applicable Applicable. Surgical instruments used in the wear and tear or improper operation. Not applicable. Can be reused, clean and sterilized before use. Not applicable

C.2.23 C.2.24

C.2.25

Continued Table 1 The characteristic problem of determining the safety Serial Number C.2.26 Determines Installation or use of medical devices requires special training or special skills? How safe use of information provided? the Whether or not affects Applicable. The installation of surgical instruments with the necessary skills to use the need for surgical (orthopedic) medical use. Applicable. The installation of surgical instruments with the necessary skills to use the need for surgical (orthopedic) medical use. Not applicable Applicable. The success of surgical instruments depends on surgeons to use clinical experience, depending on the surgeon can correct operation of surgical instruments. Not applicable Not applicable Applicable. In clinical use, some surgical instruments to be used together with the existence joints, use of the process should pay attention to the reliability of connection joints, or cause to fail. medical device Not applicable Not applicable

C.2.27

C.2.28

C.2.29

C.2.29.1 C.2.29.2

Need to establish or introduce new production processes? Successful use of medical devices, is decisive depends on human factors, such as user interface? User interface design features will result in the wrong? Medical equipment is used for distraction caused by the wrong environment? Are there parts of medical

C.2.29.3

equipment connected?

or

accessories

C.2.29.4 C.2.29.5

Are

there

control interface? Whether to display information about medical devices?

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Medical devices are controlled by the menu? Medical equipment whether the use by special request? User interface is used to trigger the user's actions? Whether to use the alarm system of medical devices? Manner in which medical devices may be intentionally misused? Whether to retain the medical equipment data on critical patient care?

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C.2.29.6

Not applicable Applicable. Surgical instruments with the necessary skills required by the surgery (orthopedics) doctors to operate. Not applicable Not applicable

C.2.29.7

C.2.29.8 C.2.30

C.2.31

Not applicable

C.2.32

Not applicable

C.2.33

Whether to retain the medical equipment data on Not applicable critical patient care?
Whether the use of medical devices depends on the basic properties? Manufacturing process should be considered in the risk Whether due to equipment caused by improper selection of materials of biological compatibility issues? Not applicable

C.2.34

35

Applicable. Surgical instruments with the necessary skills required by the surgery (orthopedics) doctors to operate.... Applicable. Improper control of such material, the occurrence of misuse, abuse will result in bio-compatibility issues; affect the product's life, resulting in surgery can not proceed.

35.1

35.2

Whether the material due to improper control devices, resulting in bio-compatibility issues and product failures?

Continued Table 1 The characteristic problem of determining the safety Serial Numbe r Determines Whether due to improper design, resulting in device products in the clinical application of the process of fracture? The processing of products possible risks? Whether or not affects

35.3

Not applicable. Surgical instruments are surgical instruments, non-implantable products

35.4

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Blanking process of the product will product of biological compatibility issues? Products in the cutting (clamp, grinding) process will produce a result of improper operation of the equipment failure factors? Products in the treatment process will produce product failure problem? Products in the polishing process will produce bio-compatibility issues? In the first washing, it will produce bio-compatibility issues?

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Applicable. Products in the blanking process, due to fracture caused by taking the wrong material or biological compatibility issues. Applicable. Products in the blanking process, due to fracture caused by taking the wrong material or biological compatibility issues. Applicable. Improper operation of the heat treatment process, not achieve the required hardness, will lead to product failure Applicable. Products in the polishing process, the pollution will be polishing paste, there is no net washing polishing paste, affecting the cleanliness of the product, resulting in bio-compatibility issues. Applicable. Products in the polishing process, the pollution will be polishing paste, there is no net washing polishing paste, affecting the cleanliness of the product, resulting in bio-compatibility issues. Not applicable. Corrosion test is mainly used to test whether the product is made of stainless steel resistant to corrosion. The liquid is often used as a bleach or disinfectant hydrogen peroxide, and has been fully diluted. Not in the product composition of the surface of residual risk. Not applicable. Laser marking does not affect the mechanical properties. Applicable. Products in the passivation process, the processing liquid is diluted nitric acid solution, such as nitric acid solution to clean without a net, there are residual elements left nitric acid solution to produce bio-compatibility issues. Products in the packaging process, due to packaging errors caused by the product mix, making products in use and the model specification does not harm patients

35.4.1

35.4.2

35.4.3

35.4.4

35.4.5

35.4.6

Products in the corrosion test whether the process of bio-compatibility issues?

35.4.7

Product marking equipment will result in fracture of the factors that produce? Product marking equipment will result in fracture of the factors that produce?

35.4.8

35.5

Products in the packaging process is causing a mixed problem? Products in the transport process caused by equipment faults will produce the factors?

35.6

Products during transport, due to the breakdown of the product packaging was damaged, resulting in surgery can not be normal.

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6.2 Risk management process Surgical Instruments products are the specific characteristics of safety-related judgments, clear and product safety hazards related to the terms of harm are the reasons for the refinement and analysis, its analysis and risk assessment, and take down measures the risk of a re-evaluation of risks, the table below:
Continued Table 2 surgical instruments list of potential hazards and measures Applicable Possible harm Whether standards Measures to the new Or related Serious Risk reduce risk Reason of risk documents Level Occurrence rank occurrence possibility (1) Do not have the Broken surgical instruments, such failure can not meet necessary skills by the surgery (bone) doctor from operating equipment. 2 2 4 Instructions in the manual Manual operation instrument No 2 1 2 ACC

Serial Number

Potential harm

Measures taken to reduce the risk analysis Serious Occurrence Risk Level possibility rank

Determine the acceptability

have been sold only to holders of Surgery

26

(Orthopaedics), MD's license.

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In the product

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29

(2) Improper use of surgical instruments, resulting in instrument fracture.

manual

for

products to be given sufficient 2 2 4 anatomical knowledge and understanding of orthopedic to with Manual operation instrument No 2 1 2 ACC

surgeons operate.

35.3

(3) designers do not follow procedures for product design and development operations

Tailor-made "design and development control procedures" and "design change control procedures", and periodically reviewed.

KH/QP-08 KH/QP-09

No

ACC

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(5) With the size of the deviation device products, resulting in the product is not fit for surgery. 4) The product does not achieve the required hardness, heat treatment process, leading to product breakage, increased wear Mechanical processing card KH/ZB-01.12 General Inspection Instructions

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In production

the

process, strict 2 2 4 control, strengthen the inspection process.

35.4.2

No

ACC

35.4.3

Formulated the "heat treatment instructions," and the special process was confirmed, while strictly enforced.

KH/JS-09.10

No

ACC

Serial Number

Potential harm

Continued Table 2 surgical instruments list of potential hazards and measures Applicable Possible harm Risk Whether standards the new reduction Or related Serious Occurrence Risk Reason of risk documents Level possibility rank approaches occurrence

Measures taken to reduce the risk analysis Serious Occurrence Risk Level possibility rank

Determine the acceptability

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Set up special library materials, Improper Biological compatibility 35.2 of the product hazards surgical instruments material control biological compatibility issues. the 2 2 4 equipment, and the establishment of special management, monthly reconciliation of debit objects, to prevent mistakes made. MWI-011 No 2

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ACC

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(1) Process may be left on surface caused harmful substances in biological compatibility problems for patients the of by to oil, after Cleaning process for each channel one by one to confirm and verify the cleaning process to develop work instructions, and products sent to the Institute of Suzhou University, Biological evaluation of radiation tests to verify the process taken by the company's reasonable. Training of cleaning operatives, cleaning work

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polishing paste cleaning the surface may still be oil, polishing paste, detergent residue composition, resulting harm patients. (2) passivation treatment, surface cleaning is not completely made acid residues, resulting in harm to patients. in to 2 5 10

the product 35.4.5

KH/JS-09.2024 SRPSU-2004-0649 SRPSU-2004-0650 SRPSU-2004-0651 SRPSU-2004-0652 SRPSU-2004-0653 SRPSU-2004-0654 SRPSU-2004-0655

No

ACC

35.4.8

10

No

ACC

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in strict accordance with the requirements of operating instructions for cleaning and make a clean record, to ensure that products meet the requirements of every cleaning. If the cleaning agent composition change or cleaning of changes in a timely manner Further validation and revalidation

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35.4.4

(3) products in the polishing, the cleaning is not complete so the surface acid residues, resulting in harm to patients.

10

No

ACC

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(4) after cutting, due to damage caused by taking the wrong material Control of the machining process to develop "machining process cards."

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35.4.1

Machining process card

No

ACC

Serial Number

Potential harm

Continued Table 2 surgical instruments list of potential hazards and measures Applicable Measures taken to reduce Possible harm Whether standards the risk analysis Measures to the new Or related Serious Occurrence Risk Serious Occurrence Risk reduce risk Reason of risk documents Level possibility rank Level possibility rank occurrence

Determine the acceptability

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In the packaging process, batch print for the same product with a bar code corresponding to the label, approved by product packaging. Packaging re-confirmed by the inspectors.

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35.5

Product mix caused by the packaging process hazards.

In the product packaging process, due to product mix, resulting in surgery products do not apply.

KH/JS-09.04 Packaging operating instructions

No

ACC

35.6

During transportation of the product hazards.

In the transport process, the products subject to the impact of external forces, the occurrence of product caused by deformation or scratches

10

Product packaging design can resist the impact of external forces for the special box packaging and make the necessary fixed.

KH/JS-09.04 Packaging operating instructions

No

ACC

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in the surface of the product. Requirements before using the operator fails to carry out sterilization and disinfection;

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infection to patients after surgery

Instructions in the use of this product is not sterile, the use of steam sterilization method.

Instruction book of Instrument sets

No

ACC

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7 criteria for acceptability 7.1 Assessment of the severity criteria

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The enterprises will be divided into five severity levels, details in Table 3.

Table 3 severity assessment chart Severity Level S S1 without any harm S2 mild damage Serious harm to S3 S4 fatal hazards Catastrophic harm S5 Severity Can be negligible Minor injury or no injury Lead to injury Resulted in one death or serious injury Led to many deaths

Evaluation ranking 0 1 2 3 4

The definition of serious injury: a, life-threatening; or b, body function or permanent damage to permanent damage to body structure; c, the injury / damage to require medical or surgical repair. 7.2 The assessment criteria probability of occurrence The orthopedic medical device companies will be divided into six levels of the quantitative analysis, see Table 4.

Table 4 assess the scale of the probability of harm

P Name probability P P1 Rare P1

Very few occurred P2 Rare P3 Incidental P4 Sometimes occurs P5 Frequent occur P6

Probability (per year)

10-6 10-4~10-6 10-2~10-4 10-1~10-2 1~10-1 1

Evaluation ranking 1 2 3 4 5 6

7.3 The estimated level of risk Orthopedic surgical instruments risk assessment based on the following formula: Risk = probability the level of severity Comprehensive description of the risks in Table 5

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Table 5 shows the level of risk comprehensive table

Possibility of occurrence P6 P5 P4 P3 P2 P1
Often Sometimes Accidental Little Very little

Severity Level

S2
Mild

S3
severe

S4
fatal

S5
catastrophic

Little Note: ACC is acceptable, ALARP area as is reasonably practicable, NAC is not acceptable. 7.4 Risk acceptance criteria The production of orthopedic surgical instruments products, integrated by the level of risk, its assessment of the acceptability criteria in Table 6.

ALARP ALARP ALARP ACC ACC ACC

NAC ALARP ALARP ALARP ACC ACC

NAC NAC ALARP ALARP ALARP ACC

NAC NAC NAC ALARP ALARP ACC

Table 6 Risk Assessment Form

1-5 (6-11) (12-17) (18-24)

The risk may be negligible Permissible risk (decrease has taken reasonable and practicable measures) Do not want to, and conditional permit risk (and then reduce the unrealistic) Does not allow the risk of

8
Verification

Department

Facts description
According to the monthly "and the rejection rate tables yield" and the annual "Product quality

Corrective measures measures

Quality Department

status

quo

and

development

-trend report", the product yield, feed rate of waste, processing waste rate the quality of work done better than the target set

--

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target 1, to

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enhance of

the

training

technical improve

Marketing Department

Technical service personnel are not sufficient; the number of the Service certificate is not enough; occasional delivery is not on time

services; service quality; 2,

increasing

the

single-package certification; 3, reasonably and

KH/JS-18.1 KH/JS-04.4

timely

delivery

according to customer requirements.

9 Summaries The company's products, surgical instruments, in accordance with ISO14971 requirements analysis, not found to harm the cause. Currently, the production of the company every step of the process of strict monitoring, the better the quality of the process to ensure product quality, meet regulatory requirements MDD93/42/EEC. All the hazards on the risk of surgical instruments are described and evaluated the risks within the acceptable range, in normal circumstances would not cause harm to operators and patients, but does not cause life-threatening, and therefore, we believe that surgery device products compared to the risks and its benefits, benefits and more risky. 10 related / supporting documents MDD 93/42/EEC (amended by 2007/47/EC) ISO 14971:2007 Medical Device Risk Management applications for medical devices KH/QP-CE03 medical device risk management procedures Department Employee Date Department Employee Date

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