BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT T25 F/UNI-SCR

    MDR report key: 3183079 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03473
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    August 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE STAR-DRIVE TIPS ARE BROKEN OFF. THE BROKEN SURFACES DO NOT SHOW ANY ANOMALIES WHAT INDICATES MATERIAL CONFORMITY AS WELL. WE CAN NOT EXACTLY EVALUATE THE REASON FOR THIS BREAKAGE. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN CAUSED THE BREAKAGE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF SCREWDRIVERS BROKE. IT IS UNKNOWN WHERE THE BROKEN PARTS ARE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283420 SCRDRIVER SHAFT T25 F/UNI-SCR HXX SYNTHES GMBH 7712102

    Patients

    Seq Age Sex Outcome Treatment
    1