STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC
Report
- Report Number
- 8030965-2024-08179
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Manufacturer
- SYNTHES GMBH
- Product Code
- HXX
- UDI-DI
- 10886982075192
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- 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. B1, B5, H1, H6: THE INITIAL COMPLAINT WAS REVIEWED, AND IT WAS DETERMINED THAT THE STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC IS NOT REPORTABLE. THIS (B)(4) WAS DETERMINED TO BE A DUPLICATE OF (B)(4). THE STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC IS CAPTURED UNDER MANUFACTURER REFERENCE NUMBER 8030965-2024-10038 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.
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. H11 ADDITIONAL NARRATIVE: B3: UNKNOWN EVENT DATE E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE TIP OF THE SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC WAS STRIPPED/TWISTED. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. THE DEVICE EXHIBITS DAMAGE CONSISTENT WITH REPEATED USE. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITIONS OF SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT WAS WORN FROM REPEATED USE AND SERVICING. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO 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 HISTORY: MANUFACTURING LOCATION: SUPPLIER- (B)(4). MANUFACTURING DATE: 10-JUN-2022. PART NUMBER: 03.130.010, STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC LOT NUMBER: 582P394 (NON-STERILE) LOT QUANTITY: (B)(4). FOUR PIECES WERE SCRAPPED IN CELL AT OP #60, VENDOR TIN COAT, FOR DESTRUCTIVE TESTING. FOUR PIECES SCRAPPED AT OP #100, FLOW INSPECT/PACK, FOR SURFACE FINISH-DISCOLORATION. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE EIGHT PIECES NOTED. INSPECTION SHEET, INCOMING INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE FOUR PIECES NOTED AT OP #100 (FLOW INSPECT/PACK). PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. CERTIFICATE OF COMPLIANCE RECEIVED FROM UNIVERSAL PUNCH FOR OP # 10 (VENDOR MACHINE) DATED 02-MAR-2022 WAS REVIEWED AND DETERMINED TO BE CONFORMING. HARDNESS SPECIFIED AT HRC 57-60; HARDNESS CERTIFIED AT HRC 58.21. INSPECTION CERTIFICATE SUPPLIED TO (B)(4) FROM (B)(4) (FOR RAW MATERIAL) DATED 17-SEP-2019 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION OF ANALYSIS SUPPLIED BY IONBOND FOR OP # 60 (TIN COAT) DATED 12-MAY-2022 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF COMPLIANCE SUPPLIED BY GENERAL MACHINE FOR OP #80 (COLORIZE) DATED 07-JUN-2022 WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE OR INSPECTION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.
THE INITIAL COMPLAINT WAS REVIEWED, AND IT WAS DETERMINED THAT THE STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC IS NOT REPORTABLE. THIS COMPLAINT, (B)(4), WAS DETERMINED TO BE A DUPLICATE OF (B)(4). THE STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC IS CAPTURED UNDER MANUFACTURER REFERENCE NUMBER 8030965-2024-10038.
IT WAS REPORTED A SCREWDRIVER SHAFT WAS RECEIVED AS BLIND UNIT WITHOUT ANY REPORT OF DEFICIENCY BEING RECEIVED. IT WAS NOT ABLE TO BE TIED TO AN EXISTING COMPLAINT. DURING RECEIPT, IT WAS DETERMINED THE TIP WAS STRIPPED. NO EVENT INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683897 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC | SCREWDRIVER | HXX | SYNTHES GMBH | 582P394 | 10886982075192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |