BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE WRENCH

    MDR report key: 11610645 · Received April 2, 2021

    Report

    Report Number
    1526439-2021-00616
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Report Date
    March 8, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXC
    UDI-DI
    10705034196770
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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. INVESTIGATION SUMMARY: BACKGROUND: 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 TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: POWER TOOLS/CALIBRATION/DAMAGE. VISUAL INSPECTION: THE TORQUE WRENCH (PART #: 277040510 / LOT #: KM831562) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED MINOR SCRATCHES WHICH WERE CONSISTENT WITH THE FIELD USAGE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS PERFORMED AT THE FSL UPS LYNDHURST, NJ SITE. THE TORQUE OF THE DEVICE MEASURED DURING CALIBRATION TESTING WAS NOT WITHIN THE SPECIFIED TORQUE RANGE. HENCE, THE TORQUE TEST FAILED LOW. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED DWG_2770-40-510, REV F TO G. COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED FOR TORQUE WRENCH (PART #: 277040510 / LOT #: KM831562). 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. 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. H3, H4, H6: DEVICE HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR TORQUE WRENCH WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM831562 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF 50 UNITS WERE RELEASED ON 08 JUN 2016 WITH NO DISCREPANCIES. 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 BATCH NULL, 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

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; 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 NOTED THAT THE TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TORQUE WRENCH. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505978 TORQUE WRENCH WRENCH HXC DEPUY SPINE INC 277040510 KM831562 10705034196770

    Patients

    Seq Age Sex Outcome Treatment
    1 TORQUE WRENCH