BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 9884184 · Received March 26, 2020

    Report

    Report Number
    2939274-2020-01531
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. D11: CONCOMITANT PRODUCTS ADDED TO COMPLAINT FOR REPORTING. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PART: 03.010.523-US, LOT: L793984, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 22. MAY 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 H6: INVESTIGATION SUMMARY BACKGROUND: 3/26/2020: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE BROKEN GREATER TROCHANTER FEMORAL RECON NAIL (FRN). WHILE THE SURGEON WAS IMPACTING THE NEW GREATER TROCHANTER FRN INTO THE PATIENT, THE DRIVING CAP SNAPPED AND BROKE OFF INSIDE THE INSERTION HANDLE THE SURGEON HAD TO GET NEW EQUIPMENT IN THE ROOM TO FINISH THE CASE. IT WAS ALSO REPORTED THAT THE SCREWDRIVER ALSO BROKE DURING THE CASE. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART# 03.033.001, LOT# 10L750732, QUANTITY 1). INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM, QTY 1, DRIVING CAP/THREADED, QTY 1. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. INVESTIGATION FLOW: DAMAGE . VISUAL INSPECTION: THE DRIVING CAP/THREADED (P/N: 03.010.523, LOT NUMBER: L793984) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE THREADED TIP HAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. DOCUMENT/SPECIFICATION REVIEW: SE_380067 REV L (CURRENT AND MANUFACTURED) WAS REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE THREADED TIP HAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE (OFF-AXIS OR EXCESSIVE HAMMER BLOWS BASED ON THE NUMEROUS DENTS ON THE PROXIMAL SURFACE). THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS HAS BEEN LAUNCHED TO ADDRESS THE IDENTIFIED ISSUE. FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT. 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.

    Description of Event or Problem · 0

    04/01/2020: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE BROKEN GREATER TROCHANTER FEMORAL RECON NAIL (FRN). WHILE THE SURGEON WAS IMPACTING THE NEW GREATER TROCHANTER FRN INTO THE PATIENT, THE DRIVING CAP SNAPPED AND BROKE OFF INSIDE THE INSERTION HANDLE THE SURGEON HAD TO GET NEW EQUIPMENT IN THE ROOM TO FINISH THE CASE. IT WAS ALSO REPORTED THAT THE SCREWDRIVER ALSO BROKE DURING THE CASE. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART# 03.033.001, LOT# 10L750732, QUANTITY 1). INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM, QTY 1, DRIVING CAP/THREADED, QTY 1. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE BROKEN GREATER TROCHANTER FEMORAL RECON NAIL (FRN). WHILE THE SURGEON WAS IMPACTING THE NEW GREATER TROCHANTER FRN INTO THE PATIENT, THE DRIVING CAP SNAPPED AND BROKE OFF INSIDE THE INSERTION HANDLE. THE SURGEON HAD TO GET NEW EQUIPMENT IN THE ROOM TO FINISH THE CASE. IT WAS ALSO REPORTED THAT THE SCREWDRIVER BROKE DURING THE CASE. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE INTRAOPERATIVE EVENT OF DRIVING CAP AND SCREWDRIVER BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENT OF FEMORAL RECON NAIL (FRN) BREAKAGE. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FRN (PART 03.033.001, LOT 10L750732, QUANTITY 1) AND 9 MM / TI CANN FRN / GT 420MM / LEFT - STERILE (PART 04.033.973S, LOT 2L80025, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347498 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L793984 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP/THREADED| INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM| RADIOLUCENT INSERTION HANDLE FRN| RADIOLUCENT INSERTION HANDLE FRN| UNK - NAILS: FEMORAL| UNK - NAILS: FEMORAL