BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 3174763 · Received June 18, 2013

    Report

    Report Number
    8030965-2013-02526
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    February 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION OF THE SCREWDRIVER OBJECT OF COMPLAINT SHOWED THAT THE TIP HAS INDEED BROKEN OFF. WE CAN UNFORTUNATELY NO LONGER ESTABLISH THE PRECISE CAUSE FOR THE PROBLEM THAT OCCURRED. THE INVESTIGATION OF THE MATERIAL AND MANUFACTURER DOCUMENTATION SHOWED NO DEVIATION FROM SPECIFICATIONS WHATSOEVER. THE FRACTURE SURFACE IS HOMOGENEOUS, WHICH ALSO PROVES THAT THE QUALITY OF THE MATERIAL WAS IRREPROACHABLE. NO PRODUCT FAILURE WAS ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWDRIVER IS BROKEN OFF. THE SURGEON DID NOT USE A TORQUE LIMITER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275625 SCREWDRIVER BIHEX Ø3 W/T-HANDLE HXX SYNTHES GMBH 3379696

    Patients

    Seq Age Sex Outcome Treatment
    1