HANDLE WITH QUICK COUPLING, SMALL
Report
- Report Number
- 2939274-2021-06730
- Event Type
- Malfunction
- Date Received
- November 17, 2021
- Date of Event
- January 1, 2021
- Report Date
- October 22, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWX
- UDI-DI
- 10886982187390
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART #: 311.43 SYNTHES LOT NUMBER: 9925607 MANUFACTURING SITE: SYNTHES JENNERSVILLE RELEASE TO WAREHOUSE DATE: NOVEMBER 11, 2015 REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE TAP HANDLE (P/N: 311.43, LOT #: 9925607) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE RETURNED QUICK COUPLING HAS A CRACK IN HANDLE AT THE REGION PROXIMAL TO DOWEL PIN. THIS CRACK IS CONSISTENT WITH CAPA. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE ROOT CAUSE OF THE DEVICE CONDITION HAS BEEN IDENTIFIED AS A DEVICE DESIGN DEFICIENCY, WHICH HAS SUBSEQUENTLY BEEN ADDRESSED THROUGH CAPA. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. THE DIAMETER AND TOLERANCE OF BORE HOLE IN THE HANDLE WAS CHANGED. ADDITIONALLY, THE DIAMETER TOLERANCE OF THE DOWEL PIN HOLE IN THE HANDLE WAS CHANGED. THESE CHANGES WERE MADE DUE TO CAPA AND ARE RELEVANT TO THE DEVICE CONDITION. CAPA WAS LAUNCHED TO IDENTIFY THE ROOT CAUSE OF HANDLE BREAKAGE AND REDUCE ITS OCCURRENCE. THROUGH THE CAPA INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE HANDLE CRACKING WAS THAT THE TOLERANCES OF THE HOLES IN THE HANDLE WERE TOO TIGHT. DEPENDING ON THE MATERIAL CONDITION, THE PRESS FIT BETWEEN THE METALLIC SHAFT/DOWEL PIN AND THEIR CORRESPONDING HOLES IN THE HANDLE COULD LEAD TO AN EXCESSIVE INTERFERENCE FIT CONDITION, IN WHICH INTERNAL STRESSES WITHIN THE HANDLE ARE CREATED. THESE INTERNAL STRESSES COULD LEAD TO THE HANDLE CRACKING AND/OR BREAKING. THE RESPECTIVE DRAWINGS WERE UPDATED THROUGH ACTION ACTIVITY AND THE DESIGN UPDATES WERE DEEMED EFFECTIVE THROUGH EFFECTIVENESS ACTION. IT WAS DETERMINED THE RISK LEVELS ASSOCIATED WITH A CRACKED COMPLAINT CONDITION WERE LOW AND MEDIUM AND DETERMINED THAT AN UPDATE TO THE RISK DOCUMENTATION WAS REQUIRED, WHICH WAS DONE THROUGH CAPA. THE CAPA INVESTIGATION DETERMINED THAT A NEW, LIMITED SCOPE DCRM WOULD BE CREATED THROUGH ACTION ACTIVITY TO DOCUMENT THE OCCURRENCE RATES, SEVERITY LEVELS AND HARMS FOR DEVICE 311.43. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE RECEIVED DEVICE AS THE INSTRUMENT WAS RECEIVED WITH A CRACK ON THE HANDLE. A VALID DESIGN DEFECT WAS IDENTIFIED AS THE ROOT CAUSE OF THE CRACKED CONDITION. CAPA WAS LAUNCHED TO ADDRESS THE DESIGN DEFECT AND WAS CLOSED AFTER EFFECTIVENESS MONITORING OF THE DESIGN CHANGES WAS DEEMED EFFECTIVE. NO MANUFACTURING ISSUES WERE IDENTIFIED THROUGH THE INVESTIGATION. A CORRECTIVE AND/OR PREVENTATIVE ACTION HAS ALREADY BEEN LAUNCHED AND COMPLETED TO ADDRESS THE DESIGN DEFICIENCY. SEE RELATED ACTION. BASED ON THESE FINDINGS, NO ADDITIONAL CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. EVENT YEAR IS REPORTED AS 2021; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION OF A LOANER SET AT FSL (B)(6) SITE. IT WAS OBSERVED THAT THE HANDLE WITH QUICK COUPLING SMALL, LOT 9925607 WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HANDLE WITH QUICK COUPLING, SMALL . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1726652 | HANDLE WITH QUICK COUPLING, SMALL | TAP,BONE | HWX | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 311.43 | 9925607 | 10886982187390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |