BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE

    MDR report key: 10931226 · Received December 1, 2020

    Report

    Report Number
    8030965-2020-09315
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 10, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819651869
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE TFNA FEM NAIL Ø9 R 130° L235 TIMO15 (P/N: 04.037.944S, LOT #: H771707) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS CRACKED AND BROKEN THROUGH THE WALLS OF THE LOCKING HOLE. THERE WERE NO DRILL MARKS ON THE DEVICE. THERE WERE SCRATCHES OBSERVED ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: THE OUTER DIAMETER OF THE NAIL NEAR THE BROKEN LOCATION WAS MEASURED AND IS WITHIN THE SPECIFICATION PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE TFNA FEM NAIL Ø9 R 130° L235 TIMO15 (P/N: 04.037.944S, LOT #: H771707). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. H3, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 07-NOV-2018. EXPIRATION DATE: 01-NOV-2028. PART NUMBER: 04.037.944S, 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. LOT NUMBER: H771707 (STERILE). LOT QUANTITY: 6. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT NUMBER: H613119. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD DATED 03-AUG-2018 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, BP55. LOT NUMBER: 1L01093. LOT QUANTITY: 94. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58. LOT NUMBER: H759038. LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80. LOT NUMBER: H731048. LOT QUANTITY: 2,162 LBS. CERTIFICATE OF TEST SUPPLIED DATED 24-AUG-2018 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 06-SEP-2018 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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.

    Description of Event or Problem · 0

    UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL ON (B)(6) 2020 DUE TO A PERTROCHANTERIC MULTI-FRAGMENT FRACTURE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DUE TO BROKEN TFNA NAIL. THE BROKEN NAIL SUCCESSFULLY REMOVED FROM THE PATIENT DURING THE REVISION PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE PERF L90 TAN (PART # 04.038.390, LOT # 39P1277, QUANTITY 1), TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), LOCKSCR Ø5 L32 F/NAILS TAN (PART # 04.005.522, LOT # 2L79243, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE PATIENT YEAR OF BIRTH IS (B)(6). EVENT OCCURRED ON AN UNKNOWN DATE IN 2020. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TFNA NAIL ON (B)(6) 2020 DUE TO A PERTROCHANTERIC MULTI-FRAGMENT FRACTURE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DUE TO BROKEN TFNA NAIL. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389807 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH H771707 07611819651869

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.038.390| LOCKSCR Ø5 L32 F/NAILS TAN| UNK - END CAPS: TFNA| UNK - END CAPS: TFNA| UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - SCREWS: LOCKING| UNK - END CAPS: TFNA| UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - SCREWS: LOCKING