BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA3 380X110MM

    MDR report key: 3251364 · Received July 29, 2013

    Report

    Report Number
    0009610622-2013-00415
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 5, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM WAS DOCUMENTED AS COMPLYING TO SPECIFICATIONS PRIOR TO DISTRIBUTION. THE DEVICE HAD BEEN IN USE FOR APPROX. 3 YEARS. AN INVESTIGATION OF THE LAG SCREWDRIVER WAS NOT POSSIBLE BECAUSE IT WAS SCRAPPED. THEREFORE THE ROOT CAUSE IS UNKNOWN. THE NEEDED TORSION FORCE TO INSERT A LAG SCREW WITH THE SCREWDRIVER IS REVEALED IN THE DHF (APPROX. 7NM) AND AN INTERNAL LAB TEST CONFIRMED THAT THIS NEEDED FORCE IS DEFINITELY REACHED (<40NM, LAB TEST# (B)(4). FURTHERMORE THE IFU STATES THAT: ¿BEFORE THE BEGINNING OF THE OPERATION, ENSURE THAT ALL COMPONENTS PREPARED FOR THE OPERATION FUNCTION CORRECTLY WITH EACH OTHER!¿ DUE TO THE PART NOT BEING RETURNED, BUT ACCORDING TO THE SURGERY SUMMARY THE FOLLOWING SCENARIO CAN BE ASSUMED: DUE TO A DAMAGE OF THE CONNECTION PINS AND / OR A DAMAGE OF THE CONNECTION THREAD OF THE SCREWDRIVER THE LAG SCREW WAS PLACED OBLIQUELY ON THE LAG SCREWDRIVER. PASSING THE OBLIQUELY ASSEMBLED LAG SCREW / LAG SCREWDRIVER OVER THE K-WIRE RESULTED IN A JAMMED K-WIRE. DURING INSERTION OF THE LAG SCREW / LAG SCREWDRIVER THROUGH THE LAG SCREW GUIDE SLEEVE THE K-WIRE WAS ALSO PUSHED FORWARD ¿ ALLEGEDLY MIGRATING INTO THE PELVIS. WHY THE LAG SCREW ¿TOOK A BAD PATH¿ IS NOT UNDERSTANDABLE. THE LAG SCREW GUIDE SLEEVE GUIDES LAG SCREW AND LAG SCREWDRIVER INTO THE CORRECT POSITION OF THE NAIL; AN INSERTION OF AN OBLIQUELY ASSEMBLED LAG SCREWDRIVER / LAG SCREW THROUGH THE SLEEVE IS NOT POSSIBLE. THAT THE SET SCREW DID NOT REACH THE LAG SCREW FLUTE TO PREVENT THE LAG SCREW FROM MIGRATION AND ROTATION WAS MOST LIKELY CAUSED DUE TO A DAMAGED LAG SCREWDRIVER PROFILE: MOST LIKELY IT WAS NOT POSSIBLE TO ROTATE THE LAG SCREW TO ITS CORRECT RADIAL POSITION (TWO FLUTES ARE VERTICAL TO NAIL AXIS). REFERRING TO ALLEGED INADEQUATE CONNECTION OF LAG SCREW / LAG SCREWDRIVER AND CONSIDERING IMPAIRED PLACEMENT OF THE SET SCREW IT WAS NOT POSSIBLE TO DETERMINE HOW THE LAG SCREW COULD HAVE BEEN PLACED INTO THE POSITION AS PRESENTED ON AVAILABLE POST-OP X-RAYS. A MORE PRECISE STATEMENT IS NOT POSSIBLE WITH THE GIVEN INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    THE PHARMACIST AT (B)(6), REPORTED THAT THE SCREW DRIVER IS NOT WORKING. THERE IS POTENTIAL FOR THE DEVICE TO LOOSEN WHICH MAY LEAD TO REVISION SURGERY. CONSEQUENCES : PRESSURE IS CONTRAINDICATED DURING 45 DAYS WHICH WILL MAKE THE PROGNOSIS WORSE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SCREW DRIVER IS NOT WORKING. THERE IS POTENTIAL FOR THE DEVICE TO LOOSEN WHICH MAY LEAD TO REVISION SURGERY. CONSEQUENCES : PRESSURE IS CONTRAINDICATED DURING 45 DAYS WHICH WILL MAKE THE PROGNOSIS WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354030 LAG SCREWDRIVER GAMMA3 380X110MM INSTRUMENT LXH STRYKER TRAUMA KIEL K241524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other