BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 10058355 · Received May 14, 2020

    Report

    Report Number
    2939274-2020-02351
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Report Date
    May 1, 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

    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: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DRIVING CAP/THREADED (PART # 03.010.523, LOT#: L812335 ) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE THREADED DISTAL TIP HAD BROKEN OFF AT THE SECOND MOST PROXIMAL THREAD FORM. THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT AND SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. THESE COSMETIC ISSUES ARE CONSISTENT WITH NORMAL WEAR. DISCOLORATION WAS OBSERVED ON THE DISTAL SHAFT END WHERE THE EDGE OF THE COMPLAINT DEVICE WOULD MEET A MATING DEVICE. ADDITIONALLY, ETCHING OF PART AND LOT NUMBER WAS FADED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. DIMENSIONAL INSPECTION: GROOVE OD AND SHAFT OD WERE MEASURED AND FOUND TO BE CONFORMING PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVING CAP/THREADED (PART # 03.010.523) AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE SECOND MOST PROXIMAL THREAD FORM, AND THEREFORE BROKEN. THE DEVICE HAD SURFACE SCRATCHES ALONG THE SHAFT AND SEVERAL DENTS ON THE TOP OF THE PROXIMAL HEAD FROM HAMMER BLOWS. DISCOLORATION WAS OBSERVED ON THE DISTAL SHAFT END WHERE THE EDGE OF THE COMPLAINT DEVICE WOULD MEET A MATING DEVICE. ADDITIONALLY, ETCHING OF PART AND LOT NUMBER WAS FADED. 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 PRODUCT ISSUE ESCALATION (PIE) HAS BEEN LAUNCHED TO ADDRESS THE IDENTIFIED ISSUE. THE NEED FOR FURTHER CORRECTIVE/PREVENTIVE ACTION WILL BE ASSESSED WITHIN THE PIE. FURTHER INVESTIGATION WILL NOT BE CONDUCTED IN THIS COMPLAINT AS IT WILL BE ADDRESSED WITHIN PIE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.523, LOT: L812335 , MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 29. JUN. 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    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. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE REPORTED: FRN INSERTION HANDLE (PART # 03.033.001, LOT # 2L17194, QUANTITY 1); THREADED DRIVING CAP (PART #03.010.523, LOT # 9065883, QUANTITY 1).

    Description of Event or Problem · 0

    UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A THREADED DRIVING CAP TIP BROKE OFF IN THE FEMORAL RECON NAIL INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, TIPS OF THE 2 THREADED DRIVING CAPS BROKE OFF IN THE FEMORAL RECON NAIL INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: FRN INSERTION HANDLE (PART # 03.033.001, LOT # UNKNOWN, QUANTITY 1), THREADED DRIVING CAP (PART #03.010.523, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 THREADED DRIVING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520067 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L812335 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP/THREADED| RADIOLUCENT INSERTION HANDLE FRN| DRIVING CAP/THREADED| RADIOLUCENT INSERTION HANDLE FRN