DEPTH GAUGE FOR SMALL SCREWS
Report
- Report Number
- 8030965-2023-01255
- Event Type
- Malfunction
- Date Received
- February 1, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTJ
- UDI-DI
- 10886982189998
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. INITIAL REPORTER IS A SYNTHES EMPLOYEE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART # 319.090. LOT # 9842083. MANUFACTURING SITE: WERK BETTLACH. RELEASE TO WAREHOUSE DATE: 15 APR 2016. 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 DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE U WAS OBSERVED ASSEMBLED AND THE TIP OF THE NEEDLE IS SLIGHTLY BEND IN DIFFERENT DIRECTIONS. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. A FUNCTIONAL TEST WAS PERFORMED TO DEVICE AND THE SLIDER CAN BE MOVED FORWARD AND BACKWARD, BUT IT IS ROUGH RUNNING. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. FUNCTIONAL ISSUES ARE MOST LIKELY DUE TO THE DEFORMED CONDITION OF THE NEEDLE. AFTER A VISUAL INSPECTION PER PROCEDURE, IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS BENT FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. 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 DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE U 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 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.
DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: CUSTOMER REPORTED A NOTICEABLE NUMBER OF ISSUES WITH VARIOUS LENGTH MEASURING DEVICES DURING THE LAST WEEKS. DESPITE CORRECT REPROCESSING AND CARE, INSTRUMENTS "HOOK" AGAIN AND AGAIN, DO NOT RUN SMOOTHLY AND THUS COMPLICATE THE SURGERIES OR EXTEND THE SURGERY TIME BECAUSE NEW TRAYS HAVE TO BE OPENED AGAIN. THE USED CLEANER IS "MEDICLEAN FORTE" FROM THE COMPANY DR. WEIGERT. THE CUSTOMER NOW ASKS FOR A CHECK OF THE INSTRUMENTS, SINCE THE LENGTH MEASURING INSTRUMENTS HAVE TO BE ORDERED ON A WEEKLY BASIS, WHICH IS NOT A PERMANENT SOLUTION IN A HOSPITAL LIKE THIS (MAXIMUM CARE PROVIDER). THERE HAS BEEN NO PATIENT HARM. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 6 OF 9 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1300473 | DEPTH GAUGE FOR SMALL SCREWS | GAUGE, DEPTH | HTJ | SYNTHES GMBH | 319.09 | 9842083 | 10886982189998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |