BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3180643 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03242
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    January 26, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 ADDITIONAL EVALUATION REVEALED THAT ONE TIP IS TWISTED AND ONE IS BROKEN OFF. THE FRACTURE FACE OF THE ONE BROKEN TIP IS HOMOGENOUS WHICH INDICATED MATERIAL CONFORMITY. BASED ON THESE FINDING WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. IT IS CLEARLY VISIBLE THAT BOTH TIPS ARE EXTREMELY TWISTED (ONE BROKEN) THIS GIVES US CLEAR INDICATION THAT FAR TOO MUCH TORQUE HAS BEEN APPLIED, DURING EITHER DIRECTION OF A LOCKING CAP. NO PRODUCT FAULT COULD BE DETECTED. 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 TIP OF A SCREWDRIVER IS BROKEN OFF. ALSO, ANOTHER SCREWDRIVER OF THE SAME PART NUMBER HAS A DEFORMED TIP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281586 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3571632

    Patients

    Seq Age Sex Outcome Treatment
    1