BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW ASNIS III Ø4.0X38MM TL13MM

    MDR report key: 4005305 · Received August 13, 2014

    Report

    Report Number
    0008031020-2014-00371
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BROKEN SCREW COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE WAS NOT FOLLOWING THE OP-TECH AND THEREFORE ATTRIBUTED TO A USER RELATED ISSUE. ACCORDING TO THE RECEIVED INFORMATION A K-WIRE FROM SPS BASIC SET WAS USED. THIS K-WIRE HAS NO THREADED TIP AS THE ASNIS III K-WIRE DOES. FURTHERMORE THE EVENT DESCRIPTION STATED THAT THE WIRE WAS BENT DURING INSERTING. REGARDLESS THIS, THE SCREW WAS INSERTED OVER THE WIRE. THE OP-TECH STATES THAT A BENDING OF THE K-WIRE MAY CAN CAUSE DAMAGE TO THE IMPLANT. PLEASE PAY ATTENTION TO THE OPERATIVE TECHNIQUE ASNIS III CANNULATED SCREW SYSTEM (REF# 982187 REV. 4): ¿NOTE: CONTACT OF AN ASNIS III SCREW WITH DENSE BONE IN A TANGENTIAL DIRECTION MAY CAUSE A DEVIATION. OF THE SCREW AND/OR A BENDING OF THE K-WIRE WHICH MAY RESULT IN DAMAGE TO THE IMPLANT. STEP 1 INSERT GUIDE WIRE USING THE O1.4/2.7MM DOUBLE DRILL GUIDE, INSERT A O1.4 × 150MM GUIDE WIRE TO THE APPROPRIATE DEPTH. USE IMAGE INTENSIFICATION TO CONTROL REDUCTION AND GUIDE WIRE PLACEMENT. PLACE ADDITIONAL GUIDE WIRES AS NECESSARY. REMOVE THE DOUBLE DRILL GUIDE. NOTE: IN DENSE BONE, PUNCTURING THE CORTEX WITH THE Ø1.4 × 150MM DRILL BIT TO INITIATE THE WIRE MAY REDUCE HEAT BUILD-UP AND/OR DEFLECTION OF THE WIRE.¿ [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. 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 WIRE WAS BENT WHEN INSERTING. SCREW WAS INSERTED OVER THE WIRE, CAUSING THE WIRE TO BREAK. WHEN REMOVING THE WIRE, THE CUTTING FLUTE ON THE SCREW BROKE. A SMALL PART OF THE SCREW WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WIRE WAS BENT WHEN INSERTING. SCREW WAS INSERTED OVER THE WIRE, CAUSING THE WIRE TO BREAK. WHEN REMOVING THE WIRE, THE CUTTING FLUTE ON THE SCREW BROKE. A SMALL PART OF THE SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483784 CANNULATED SCREW ASNIS III Ø4.0X38MM TL13MM SCREW, FIXATION, BONE HWC STRYKER TRAUMA SELZACH R28003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other