BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 FINAL TIGHTENER HANDLE,

    MDR report key: 9107636 · Received September 23, 2019

    Report

    Report Number
    1526439-2019-52136
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Report Date
    August 29, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034214863
    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). UDI: (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 VIPER2 FINAL TIGHTENER HANDLE [PRODUCT CODE: 2867-45-500, LOT NUMBER: GB47553] 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. TORQUE WRENCH WAS TESTED FOR TORSIONAL TEST PER TM-100331, REV 15 FOR MOUNTZ AND TELEDYNE TORQUE SERVICE LIMIT RANGE: (74.4 - 85.6 IN-LBS.) ON A TORQUE METER (GAGE ID#: 78862). EIGHTEEN READINGS WERE RECORDED AT EACH TORQUE SETTING. IT WAS NOTED THAT THE HANDLE WAS TORQUEING ABOVE THE UPPER SPECIFICATION LIMIT (USL) OF (74.4 - 85.6 IN-LBS.) RANGE A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VIPER2 FINAL TIGHTENER HANDLE WAS CONDUCTED 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. 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 TORQUEING CANNOT BE POSITIVELY DETERMINED. ALTHOUGH NOT PROVEN, THE MOST PROBABLE ROOT CAUSE FOR THE OVER TORQUEING 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 (74.4 - 85.6 IN-LBS.) RANGE SPECIFIED IN TM-100331 REV. 15. 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 (B)(6). 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
    896904 VIPER2 FINAL TIGHTENER HANDLE, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC 286745500 GB47553 10705034214863

    Patients

    Seq Age Sex Outcome Treatment
    1