2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM
Report
- Report Number
- 8030965-2023-04097
- Event Type
- Malfunction
- Date Received
- April 4, 2023
- Date of Event
- January 11, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWC
- UDI-DI
- 07611819827301
- PMA / PMN Number
- K113364
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- 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. D10: DSTE OF CONCOMITANT THERAPY IS (B)(6) 2023. H3, H6: PART: 402.214S, LOT: L275256, MANUFACTURING SITE: WERK SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 11 JANUARY 2017, EXPIRATION DATE: 01 JANUARY 2027. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART: 402.214, NON-STERILE LOT: L251185, MANUFACTURING SITE: WERK MEZZOVICO, SUPPLIER: NA, RELEASE TO WAREHOUSE DATE: 29 DECEMBER 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 SCREW RECESS OF LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L14 TA, P/N: 402.214S, LOT: L275256, WAS MACHINED INCOMPLETELY. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L14 TA, P/N: 402.214S, LOT: L275256 AND MET SPECIFICATIONS. A LOCKING SCREW BELONGING TO PRODUCT FAMILY 402.214S WAS PREVIOUSLY INVESTIGATED BY JABIL. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. A FUNCTIONAL TEST TO ASSESS THE ALLEGATION OF UNABLE TO ASSEMBLE WAS NOT CONDUCTED SINCE THE MATING DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON THE CONDITION OF THE RETURNED DEVICE, IT IS REASONABLE TO CONCLUDE THAT THE DEVICES WERE NOT ABLE TO ASSEMBLE PROPERLY. 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 CONDITION OF THE LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L14 TA, P/N: 402.214S, LOT: L275256 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED FEATURE: LENGTH, HEAD DIAMETER MEASURED DIMENSION: LENGTH HEAD DIAMETER SCREW DIAMETER RESULT: CONFORMING. 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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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.
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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PROCEDURE THE SCREW HEAD WOULDN'T FIT INTO THE SCREW RECESS. A NEW SCREWDRIVER WAS USED, BUT THAT DIDN¿T FIT EITHER. ANOTHER SCREW WAS USED. NO PATIENT HARM AND THIRTY(30) MINUTES OF SURGICAL DELAY WAS NOTED. THIS REPORT IS FOR ONE (1) 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383451 | 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM | SCREW, FIXATION, BONE | HWC | SYNTHES GMBH | L275256 | 07611819827301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNK - SCREWDRIVERS |