BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S

    MDR report key: 3141397 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02562
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 12, 2011
    Report Date
    February 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND SHOWED CONFORMITY WITH THE MATERIAL AND MANUFACTURING SPECIFICATIONS AT THE TIME IT LEFT OUR MANUFACTURING PLANT. THE VISUAL INSPECTION OF THE COMPLAINED HEX SCREWDRIVER HAS SHOWN THAT THE CENTER PIN IS COMPLETELY BROKEN OFF DUE TO MECHANICAL OVERLOADING DURING USE. NO PRODUCT OR MATERIAL RELATED CONDITION WAS FOUND. THE INVESTIGATION HAS DETERMINED THIS COMPLAINT TO BE INVALID.

    Description of Event or Problem · 1

    THE DISTAL PIN IS BROKEN OFF THE SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245187 SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S HXX SYNTHES GMBH 3500855

    Patients

    Seq Age Sex Outcome Treatment
    1