BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH

    MDR report key: 6910409 · Received October 3, 2017

    Report

    Report Number
    1526439-2017-10790
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 7, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXC
    UDI-DI
    10705034196770
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURN DEVICE NOTED EXTENSIVE SURFACE WEAR. BENCH TESTING WAS PERFORMED AND DEVICE WAS ABOVE SPECIFIED GUIDELINES. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO LACK OF MAINTENANCE DURING ITS TIME IN USE. DEVICE IS OVER SEVEN YEARS OLD. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, 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

    DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE FINDINGS. 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

    ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS UNKNOWN. WHILE THE SURGEON WAS MAKING A FINAL TIGHTENING WITH TORQUE WRENCH (PART#: 277040510, LOT#: UNK), CUT OUT ISSUE WAS HAPPENED TO A SCREW (PART# & LOT#: UNK), WHICH RESULTED IN A 30-MINUTE DELAY OF THE SURGICAL OPERATION. DUE TO THIS ISSUE, THE SURGEON ADDED ADDITIONAL FIXATION TO THE PATIENT. THE SURGEON COMMENTS THAT THE TORQUE OF THIS TORQUE WRENCH IN QUESTION MIGHT BE LARGER THAN USUAL. WE ARE REQUESTED BY THE HOSPITAL TO INVESTIGATE WHETHER ITS TORQUE VALUE WAS NORMAL OR NOT. ADDITIONAL INFORMATION: ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS L4 ¿ L5. AT FIRST, WHEN THE SURGEON TIGHTENED THE SCREW AT L5, HE FELT THAT IT WAS A BIT TIGHTER THAN USUAL. WHEN HE MOVED TO L4, HE REALIZED THAT THE TORQUE OF TORQUE WRENCH DID NOT WORK AT L4. HE WENT ON TIGHTENING THE SCREW AT L4 AND THEN THE SCREW GOT CUT OUT. AS A RESULT, THE FIXED AREA WAS EXTENDED TO L3 ¿ L5. THE SURGERY WAS COMPLETED WITH A 30-MINUTE EXTENSION. WE ARE REQUESTED BY THE SURGEON TO INVESTIGATE WHETHER THE TORQUE IS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690398 MONARCH WRENCH HXC DEPUY SYNTHES SPINE 277040510 E0410 10705034196770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other