BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE WRENCH

    MDR report key: 9107736 · Received September 23, 2019

    Report

    Report Number
    1526439-2019-52141
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Report Date
    August 29, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXC
    UDI-DI
    10705034196770
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (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: THE TORQUE WRENCH [PRODUCT CODE: 277040510, LOT NUMBER: E0908] WAS NOT RETURNED TO THE COMPLAINT HANDLING UNIT (CHU). INSTEAD, THE SAMPLE WAS RETURNED TO 5 STAR FOR REWORK AND RECALIBRATION. FIVE STAR SURGICAL, INC HAS PERFORMED THE TORSIONAL TEST FOR THE TORQUE WRENCH AND PROVIDED THE RESULTS TO THE COMPLAINTS HANDLING UNIT. IT WAS NOTED THAT THE DEVICE COULD NOT BE ADJUSTED TO THE 100LBF. IN SETTINGS BY HAND. TORQUE WRENCH WAS TESTED FOR TORSIONAL TEST PER TM-100331, REV 15 FOR MOUNTZ AND TELEDYNE TORQUE SERVICE LIMIT RANGE: (55.8 - 64.2 IN-LBS) AND (74.4 - 85.6 IN-LBS.) ON A TORQUE METER (GAGE ID#: (B)(4)). SIX READINGS WERE RECORDED AT EACH TORQUE SETTING. IT WAS NOTED THAT THE HANDLE WAS TORQUING ABOVE THE UPPER SPECIFICATION LIMIT (USL) OF (55.8 - 64.2 IN-LBS.) AND (74.4 - 85.6 IN-LBS.) RANGE SPECIFIED IN TM-100331 REV. 15 (SEE ATTACHED FILE) THE WRENCH WAS NOT TESTED FOR OTHER TORQUE SET POINT, IT COULD NOT BE ADJUSTED TO THE OTHER SETTINGS BY HAND. THE TORQUE WRENCH MAY BE STUCK AT ITS CURRENT SETTING DUE TO WEAR AND/OR RUST TO THE INTERNAL COMPONENTS OF THE DEVICE, IRREGULAR MAINTENANCE, AND LACK OF LUBRICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED ON THE TORQUE WRENCH (PRODUCT CODE: 277040510, LOT NUMBER: E0908) NO MANUFACTURING RECORDS COULD BE LOCATED FOR THIS PART/LOT COMBINATION. IF FURTHER INFORMATION BECOMES AVAILABLE THIS DHR CAN BE REVISITED. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE TORQUE WRENCH OVER TORQUING CANNOT BE POSITIVELY DETERMINED. ALTHOUGH NOT PROVEN, THE MOST PROBABLE ROOT CAUSE FOR THE OVER TORQUING OF THE HANDLE CAN BE ATTRIBUTED TO LACK OF MAINTENANCE DURING ITS TIME IN USE, RESULTING IN THE TORQUE HANDLE EXERTING MORE TORQUE THAN ITS UPPER SPECIFICATION LIMIT (USL) OF (55.8 - 64.2 IN-LBS.) AND (74.4 - 85.6 IN-LBS.) RANGE SPECIFIED IN TM-100331 REV. 15. A DEFINITIVE ROOT CAUSE FOR THE TORQUE WRENCH JAMMING CANNOT BE POSITIVELY DETERMINED. ALTHOUGH NOT PROVEN, THE MOST PROBABLE ROOT CAUSE OF THE TORQUE WRENCH NOT BEING ABLE TO HAVE ITS TORQUE SETTING CHANGED CAN BE ATTRIBUTED TO LACK OF MAINTENANCE DURING ITS TIME IN USE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY NOW AS NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED 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

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE HAS FAILED DURING THE CALIBRATION DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897661 TORQUE WRENCH WRENCH HXC DEPUY SPINE INC 277040510 E0908 10705034196770

    Patients

    Seq Age Sex Outcome Treatment
    1