Complaint Handling and Trending At Stryker Orthopaedics

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1 Complaint Handling and Trending At Stryker Orthopaedics John Lynch Reliability Engineer Stryker Orthopaedics Richard Campos Senior Reliability Engineer Stryker Orthopaedics March 8 10, 2011 Hyatt Regency Cincinnati, OH

Our Company Stryker A broad based global leader in medical technologies Founded 1941 by Dr. Homer Stryker Company went public in 1979 18,000 employees $7.3B sales in 89 countries for 2010 $4.

2 Our Company Stryker A broad based global leader in medical technologies Founded 1941 by Dr. Homer Stryker Company went public in ,000 employees $7.3B sales in 89 countries for 2010 $4.3B worldwide sales of orthopaedic implants in 2010 Diversified businesses Joint reconstruction of knees, hips, shoulders Operating room equipment Medical beds and stretchers Craniomaxillofacial Endoscopy Trauma Spine

3 Broad Product Range

4 Joint Replacement The hip joint is a ball-and-socket joint, formed by the femoral head at the upper end of the thigh bone, and the rounded socket, or acetabulum, in the pelvis. An artificial joint is a medical option available to relieve pain and restore quality of life to patients with joint degeneration or arthritis. JOHNNY BENCH

5 System Overview Data Triggers Analysis Integrated data handling, risk management, and analytics

6 Data Complaint Handling Triggers Analysis

7 Why do we investigate complaints We want to improve our products for our users and patients Regulations

8 What is a complaint? Any written, oral, or expression of dissatisfaction relative to the identity, quality, Voice durability, of Customer reliability, - A customer safety, has effectiveness, had an unsatisfactory performance, experience or appearance with our product

9 Where do we monitor complaints?

10 Intake Tools Required Best practices SOPs Forms Hotline Expedited device returns

11 Data Management Tools Required Validated database 3 rd party solution Company specific solution Key Attributes Time Bases Event types Root Cause types

12 Voices of Customer (VOC) Damaged blister Discrepancy noted in blister Contents rattling in box Dent on inner blister Blister does not look right Stem moved in packaging Packaging damaged Failed pre-op inspection

13 Translating VOC to Event Types Damaged Shipping damage blister Discrepancy Shipping noted damage in blister Contents Shipping rattling damage in box Dent Shipping on inner damage blister Blister Shipping does not damage look right Stem Shipping moved in packaging damage Packaging User mishandling damaged Failed User pre-op mishandling inspection

14 Categorization of complaints Shipping damage Shipping damage Shipping damage Shipping damage Shipping damage Shipping damage User mishandling User mishandling

15 Data Risk Management and Trending Triggers Analysis

16 Value Stream

17 Risk Management Process ANALYSIS PRODUCT 1 Hazard & Harm lists EVALUATION Acceptability criteria Plan Act Do Check CONTROL Effective Measures Plan Do REPORT Controlled Documents Act Check POST / PRODUCTION PRODUCT 2 Surveillance

18 Product Complaint Trending 1 2 Scope the Complaints 3 Scope Sales Estimate the complaint rate 4 Compare to acceptable rate What is the valid statistical rate? 5 Communicate to Stakeholders What was the risk assessment at product launch? Corrective Action How are the findings effectively communicated? How many patient exposures? What is the issue?

19 Scoping Complaints Pareto the issue 1 2 By supplier, tool, batch, distributor, shipper By product line, brand, family, specific item By region, country, facility, user, patient By failure mode, hazard, harm (severity) Timebase the issue Choice of date affects sales association (event, surgery, production ) Choice of binning affects sample size (monthly, quarterly ) Examples: For implantable devices, timebase on the implantation date For corrective action effectivity, timebase on the production date

20 Scoping Sales Product Association Determine optimal product association 1 Example: Reusable Medical Instrument Medical Uses Pareto the issue By bulk complaint to sales # units shipped # implants sold Timebase reminder Match timebase chosen for complaint scoping

21 Complaint Rate Estimation Valid Statistical Technique Linear regression Y = cumulative complaints X = cumulative sales Speed = Rise over Run c1+c2 The Speed at the second data position is Cumulative Complaints c1 s1 s1+s2 (c1+c2) - c1 (s1+s2) - s1 c2 = = Complaint Rate s2 Cumulative Sales

22 Compare to Acceptable Rate Review Product Risk Management files Risk Tables, Fault Trees, FMEAs Determine risk ratings for subject issue Compare rate and severity to risk ratings Is this a new risk? If known, is there residual risk? Example of documented Risk Assessment High O5 Acceptable occurrence Moderate Low Remote Negligible O4 O3 O2 O1 S0 S1 S2 S3 S4 S5 None Limited Temporary or Reversible Intervention Required Permanent Impairment Death Acceptable Severity

Communicate to Stakeholders 1 2 3 4 5 Executive Issue Summary Issue description Associated products

23 Communicate to Stakeholders Executive Issue Summary Issue description Associated products Harms and Hazards Supply chain scope Statistical method Statistical results Risk reassessment Action request

24 Let s drive an example

25 Hip Stem Packaging Damage PETG double blister package, sealed with Tyvek lids and retaining foam

26 Causal associations Double blister break: Inner blister break: Readily detected and replaced Sterility not compromised

Product Complaint Trending 3 4 5 Scope the Complaints 2 1 VOC Damaged Hip stem PETG Package Blisters Database 95 % Coded events

27 Product Complaint Trending Scope the Complaints 2 1 VOC Damaged Hip stem PETG Package Blisters Database 95 % Coded events as Damaged Package Timebase Binning by Production Date Pareto 98% complaints from 1 Product Family Harms Minor delay in surgery

28 Product Complaint Trending Scope the Sales 2 1 Association Hip stem sales Timebase Binning by Production Date Pareto 76 % from Region1 (worst case distribution path)

29 Product Complaint Trending Estimate the Complaint Rate 2 1 Technique Linear regression for Region 1 Fit quality Residuals 99% adjusted R-square Normal, independent, homogeneous Cumulative Complaints Cumulative Sales

30 Product Complaint Trending Risk Re-assessment and Communication Action is Needed! Occurrence: Trend rate Severity: Event details

31 So How did We Do? The Package was redesigned to secure the stem for the most stringent distribution path The Risk reduction was Effective Cumulative Complaints Complaints level off Cumulative Sales

32 Conclusion Our integrated processes effectively reduce patient and user risk Pillars Complaint Handling Risk Management Trending Supporting pillars Corrective Action system Decision makers

33 Thank You for your Attention Any Questions?

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