BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 FINAL TIGHTENER HANDLE,

    MDR report key: 9078498 · Received September 17, 2019

    Report

    Report Number
    1526439-2019-52094
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034214863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: GB0810] 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 HANDLE AND PROVIDED THE RESULTS TO THE COMPLAINTS HANDLING UNIT. TORQUE WRENCH WAS TESTED FOR RANGE (74.4-85.6 LBF.IN) ON A TORQUE METER (GAGE ID#: 78862). 18 READINGS WERE RECORDED AT MOUNTZ AND TELEDYNE TORQUE SERVICE LIMIT RANGE. IT WAS NOTED THAT THE HANDLE WAS TORQUEING ABOVE THE UPPER SPECIFICATION LIMIT (USL) OF (74.4-85.6 LBF.IN) 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 VIPER2 FINAL TIGHTENER HANDLE 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 LBF.IN) 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 · 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: THE VIPER2 FINAL TIGHTENER HANDLE [PRODUCT CODE: 2867-45-500, LOT NUMBER: GB0810] WAS NOT RETURNED TO THE COMPLAINT HANDLING UNIT (CHU). INSTEAD, THE SAMPLE WAS RETURNED TO 5 STAR FOR REWORK AND RECALIBRATION. THE SAMPLE IS NOT EXPECTED TO BE RETURNED AT THIS TIME. 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 PER PROCEDURE (B)(4). WITHOUT THE DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS NO ISSUES COULD BE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS PRODUCT. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF MORE INFORMATION AND/OR THE COMPLAINT SAMPLE BECOME AVAILABLE AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE PRODUCT WILL BE EVALUATED. 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

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. (B)(4). 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, 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 THAT ON (B)(6) 2019, THE TORQUE CALIBRATION FAILURE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TORQUE DRIVER. THIS IS REPORT 4 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870695 VIPER2 FINAL TIGHTENER HANDLE, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC 286745500 GB0810 10705034214863

    Patients

    Seq Age Sex Outcome Treatment
    1