BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING

    MDR report key: 11156877 · Received January 12, 2021

    Report

    Report Number
    2939274-2021-00233
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Report Date
    December 16, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034715032
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING (P/N: 03.614.035, LOT #: H131754-12) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE ETCH ON THE DEVICE WAS FADED BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED DURING THE SERVICE AND REPAIR EVALUATION. THE HIGHEST TORQUE OF THE DEVICE MEASURED DURING CALIBRATION TESTING WAS NOT WITHIN THE SPECIFIED TORQUE RANGE OF THE DEVICE PER RELEVANT DRAWINGS. HENCE, THE TORQUE TEST FAILED HIGH. SERVICE AND REPAIR EVALUATION: DURING EVALUATION AT SERVICE AND REPAIR, THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING WAS FOUND TO HAVE FAILED CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED TORQUE TESTING. END OF SERVICE LIFE IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS FAILED HIGH. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING (P/N: 03.614.035, LOT #: H131754-12). AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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 # 03.614.035. SYNTHES LOT NUMBER: H131754-12. SUPPLIER LOT NUMBER: H131754-12. RELEASE TO WAREHOUSE DATE: 28.OCT.2016. SUPPLIER: (B)(4). NO NCR¿S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH 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.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ON (B)(6) 2020, DURING EVALUATION AT SERVICE AND REPAIR, THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52077 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.614.035 H131754-12 10705034715032

    Patients

    Seq Age Sex Outcome Treatment
    1