BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3173875 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03399
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    September 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 TIP BROKE OFF. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THE STRESS MARKS AT THE TOP AND THE BOTTOM OF THIS DEVICE SHOW THAT THIS INSTRUMENT WAS USED OFTEN. IT IS VISIBLE THAT THE TIP WAS TWISTED BEFORE THE BREAKAGE. BOTH PINS HAVE A DEFORMATION ON ONE SIDE. THIS INDICATES THAT TOO MUCH TORQUE WAS APPLIED TO THIS INSTRUMENT WHILE TIGHTENING A SCREW. MECHANICAL OVERLOAD CAUSED THE BREAKAGE. 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 THE SCREW DRIVER BROKE OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274386 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3087297

    Patients

    Seq Age Sex Outcome Treatment
    1