BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET

    MDR report key: 3865166 · Received June 11, 2014

    Report

    Report Number
    0008031020-2014-00283
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMERY: THE REPORTED EVENT THAT TIP OF THE SCREWDRIVER SHEARED OFF COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE EVENT DESCRIPTION, THE ROOT CAUSE MOST PROBABLY WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT DESCRIPTION STATED THAT NO TORQUE LIMITER WAS USED, AN APPLICATION OF TOO HIGH TORSIONAL FORCES IS LIKELY. PLEASE PAY ATTENTION TO THE OP-TECH FOR AXSOS LOCKING PLATE SYSTEM (LITERATURE NUMBER: 982275 LOT E2208): ¿FINAL TIGHTENING OF LOCKING SCREWS SHOULD ALWAYS BE PERFORMED MANUALLY USING THE TORQUE LIMITING ATTACHMENT (REF 702750) TOGETHER WITH THE SOLID SCREWDRIVER T15 (REF 702753) AND T-HANDLE (REF 702427)(FIG. 10). NOTE: ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, BUT DO NOT APPLY AXIAL FORCE DURING FINAL TIGHTENING. [¿] 5. DO NOT USE POWER FOR FINAL INSERTION OF LOCKING SCREWS IT IS IMPERATIVE TO ENGAGE THE SCREW HEAD INTO THE PLATE USING THE TORQUE LIMITING ATTACHMENT. ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, BUT DO NOT APPLY AXIAL FORCE DURING FINAL TIGHTENING. IF THE SCREW STOPS SHORT OF FINAL POSITION, BACK UP A FEW TURNS AND ADVANCE THE SCREW AGAIN (WITH TORQUE LIMITER ON).¿ [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INDEX TRAUMA SURGERY WHILE TIGHTENING THE LOCKING SCREW WITHOUT THE TORQUE LIMITER, THE TIP OF THE SCREWDRIVER SHEERED OFF. THE PIECES OF THE SCREWDRIVER WERE RETRIEVED. THE SURGEON THEN OPTED TO REMOVE THE SCREW AND IMPLANT A NEW ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INDEX TRAUMA SURGERY WHILE TIGHTENING THE LOCKING SCREW WITHOUT THE TORQUE LIMITER, THE TIP OF THE SCREWDRIVER SHEERED OFF. THE PIECES OF THE SCREWDRIVER WERE RETRIEVED. THE SURGEON THEN OPTED TO REMOVE THE SCREW AND IMPLANT A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345596 SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other