BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE WRENCH

    MDR report key: 9681736 · Received February 7, 2020

    Report

    Report Number
    1526439-2020-00508
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Report Date
    January 17, 2020
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXC
    UDI-DI
    10705034196770
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: INVESTIGATION SUMMARY. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE TORQUE WRENCH (P/N: 277040510, LOT #: KM860373) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WERE SCRATCHES ON THE DEVICE BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS PERFORMED AT THE FSL UPS HARRISBURG SITE. UPON THE FUNCTIONAL TEST, IT WAS OBSERVED THAT TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 54 IN-LBS TO 66 IN-LBS. THE TORQUE TESTED LOW ¿ 50.08 IN-LBS CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICES? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED AS THE COMPLAINT CONDITION OF THE DEVICE FAILED LOW IN TORQUE TEST WAS IRRELEVANT FOR DIMENSIONAL ANALYSIS. DOCUMENT/SPECIFICATION REVIEW : BASED ON THE DATE OF MANUFACTURE OF THE DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED . COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED FAILED LOW IN TORQUE TEST. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION : THE COMPLAINT CONDITION IS CONFIRMED FOR THE TORQUE WRENCH (P/N: 277040510, LOT #: KM860373). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO DEVICE MAINTENANCE DEFICIENCY. 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 HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR TORQUE WRENCH WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM860373 WAS RELEASED IN A SINGLE BATCH. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY REVIEW: THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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 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 AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 54-66. THE TORQUE TESTED LOW ¿ 50.08. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143380 TORQUE WRENCH WRENCH HXC DEPUY SPINE INC 277040510 KM860373 10705034196770

    Patients

    Seq Age Sex Outcome Treatment
    1