BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM

    MDR report key: 1723986 · Received June 10, 2010

    Report

    Report Number
    9610622-2010-00240
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 20, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - FUNCTIONAL CHECK - WE PERFORMED A SIMULATION OF THE PRE-OPERATIVE CHECK WHICH IS REQUIRED IN THE INSTRUCTIONS FOR USE TO CHECK THE CLAMPING FUNCTION. FUNCTION TEST PERFORMED ON THE DEVICE REVEALED THAT MECHANICAL FUNCTION INCLUDING CLAMPING OF THE SET SCREW IS GIVEN IN FULL ALTHOUGH THE CLAMPING RING IS DEFORMED. REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE DHR FOR THE DEVICE (LOT CODE K218225) REVEALED NO DISCREPANCIES. DEVIATIONS IN THE MFG DOCUMENTS WERE NOT FOUND. IT CAN BE ASSUMED THAT INSERTING OF THE SET SCREW HAD BEEN CARRIED OUT USING THE INTENDED SCREWDRIVER BIT FOR SET SCREW (GTI SYSTEM). THEN, DURING EXTRACTION SURGERY, THE SEIZED SET SCREW WHICH HAD BEEN INSERTED UNDER MISALIGNMENT COULD NOT BE EXTRACTED WITH THE USED AND NON-INTENDED FLEXIBLE GAMMA3 SET SCREWDRIVER EVALUATION REVEALED THAT THE REPORTED EVENT IS NOT LINKED TO ANY DEFICIENCY OF THE DEVICE, BUT RATHER TO NON-INTENDED INTRA-OPERATIVE USE OF THE PRODUCT AT USER SITE.

    Description of Event or Problem · 1

    THE HEAD OF THEATER, REPORTS VIA OUR SALES REP, THAT THE RING AT THE TIP IS OUT OF FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM INSTRUMENT HXX STRYKER OSTEOSYNTHESIS KIEL NA K218225

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other