BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUS SCREW ?4.0X34MM

    MDR report key: 2685225 · Received July 31, 2012

    Report

    Report Number
    8031020-2012-00169
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    STRYKER TRAUMA AG
    Product Code
    HWC
    PMA / PMN Number
    K050512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. IF ADD¿L INFO IS RECEIVED IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR: 8031020-2012-00170.

    Description of Event or Problem · 1

    IT WAS REPORTED, ¿PT ADMITTED FOR TIBIAL PLATEAU FRACTURE. PROXIMAL LATERAL TIBIA PLATES WERE SHIPPED IN FROM (B)(4) ON DAY OF EVENT WITH CORRECT INSTRUMENTATION AND SCREW CADDY. INSTRUMENTS AND IMPLANTS WERE TAKEN THROUGH STERILE PROCESSING DEPT. AND STERILIZED ACCORDINGLY FOR CASE. INCISION WAS MADE TO EXPOSE THE JOINT AND PROXIMAL LATERAL TIBIA PLATE WAS FIXATED WITH PINS AFTER FRACTURE REDUCTION. FIRST SCREW PLACED INTO METAPHYSIS AND SURGEON CONTINUED BY FIXATING SHAFT SCREWS. NEUTRAL DRILL GUIDE PLACED INTO NON-LOCKING SCREW HOLE. BONE WAS DRILLED BI-CORTICALLY AND SCREW INSERTED FIRST BY HAND, FOLLOWED BY POWER AT SLOW SPEED. SPEED OF DRILL ACCELERATED, BREAKING SCREW APPROX. 3-4 THREADS BELOW HEAD OF SCREW. SCREW WAS LEFT IN SHAFT AS THE SURGEON CONTINUED ON TO NEXT DISTAL SCREW HOLE. NEUTRAL DRILL GUIDE PLACED INTO NON-LOCKING SCREW HOLE AND DRILLED BI-CORTICALLY, THEN OVER DRILLED WITH 3.5 DRILL. INSERTION OF SECOND SCREW STARTED BY HAND AND CONTINUED BY HAND. AS SECOND SCREW SEATED, THE SCREW HEAD BROKE OFF APPROX. 3-4 THREADS BELOW THE HEAD OF THE SCREW, AGAIN LEAVING THE SCREW IN THE BONE. SURGEON THEN MOVED ON TO FIXATE SCREWS IN REMAINING LOCKING AND NON-LOCKING SHAFT HOLES. PROXIMAL LOCKING SCREWS WERE THEN PLACED, HOLDING FRACTURE REDUCED. SURGEON WAS THEN SATISFIED WITH REDUCTION AND ELECTED NOT TO ATTEMPT TO RETRIEVE BROKEN SCREWS. SURGEON THEN ELECTED TO CLOSE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUS SCREW ?4.0X34MM IMPLANT HWC STRYKER TRAUMA AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other