BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING

    MDR report key: 9322313 · Received November 14, 2019

    Report

    Report Number
    2939274-2019-62197
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Report Date
    October 28, 2019
    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
    NC, 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. PART: 03.614.035. SYNTHES LOT: 6153478. SUPPLIER LOT: 87625. RELEASE TO WAREHOUSE DATE: JUNE 26, 2009. SUPPLIER: NEMCOMED. NO NONCONFORMANCE REPORTS (NCRS) 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. SERVICE & REPAIR EVALUATION: DURING TESTING AT SERVICE AND REPAIR, THE REPAIR TECHNICIAN REPORTED THE TORQUE LIMITING HANDLE WITH QUICK COUPLING FAILED IN CALIBRATION. THE CAUSE OF THE ISSUE IS FAILED HIGH IN CALIBRATION TESTING. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) OBSERVED THAT THE GIVEN DEVICE TORQUE LIMITING HANDLE WAS RECEIVED INTACT WITH LIGHT SURFACE WEAR. FUNCTIONAL TESTING FUNCTIONAL EVALUATION WAS PERFORMED BY THE TECHNICIAN AND STATED THAT THE DEVICE FELL ABOVE THE HIGH END OF THE ALLOWABLE TORQUE RANGE ON ONE OF THE 16 LOBE TESTS. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WAS REVIEWED; TORQUE LIMITING HANDLE QUICK COUPLING REVIEW OF THE MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE 2 NM TORQUE LIMITING HANDLE WITH QUICK COUPLING FAILED LOW IN CALIBRATION TEST. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE 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. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES 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

    IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING TESTING AT SERVICE AND REPAIR ON (B)(6) 2019, THE TORQUE LIMITING HANDLE WITH QUICK COUPLING FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118977 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.614.035 6153478 10705034715032

    Patients

    Seq Age Sex Outcome Treatment
    1