BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER

    MDR report key: 3031920 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-00978
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR THE PRODUCT INDICATE NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THREE OF THE FOUR FLANKS ARE BROKEN OFF. THE REMAINING FLANK IS DEFORMED. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE AT THE TIP. IT IS CLEARLY VISIBLE THAT THE REMAINING FLANK IS STRONGLY BENT IN COUNTER-CLOCKWISE DIRECTION. THIS INDICATES THAT A MECHANICAL OVERLOAD DURING THE LOOSENING OF A PROBABLY BLOCKED SCREW COULD HAVE CAUSED THIS BREAKAGE. THE WEAR MARKS AT THE REMAINING FLANK ALSO INDICATE THAT THIS WAS AN OFTEN AND INTENSE USED SCREWDRIVER, SO WEAR AND TEAR COULD ALSO HAVE PLAYED A CERTAIN ROLE.

    Description of Event or Problem · 1

    WHILE USING A SCREWDRIVER, TO REMOVE 2.4 MM MODULAR HAND SCREW, DURING A HARDWARE REMOVAL PROCEDURE OF THE LEFT FOREARM, THE TIP OF THE SCREWDRIVER BROKE OFF. THE TIP WAS RECOVERED AND A REPLACEMENT SCREWDRIVER WAS USED. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY WITH SLIGHT DELAY.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136158 CRUCIFORM SCREWDRIVER HXX HXX SYNTHES GMBH 3053652

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR