BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3161296 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02941
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    November 3, 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

    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 TIPS ARE BROKEN OFF. THE FRACTURE FACES ARE HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE PROVIDED INFORMATION, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. THERE ARE VARIOUS REASONS FOR SUCH A BREAKAGE. NOT USING A TORQUE LIMITER, USING A TORQUE LIMITER WHICH IS OUT OF RANGE, APPLYING TOO MUCH LATERAL STRESS, NOT INSERTING THE TIP COMPLETELY INTO THE RECESS OF THE COUNTERPART OR A COMBINATION OF THESE CAUSES CAN LEAD TO SUCH BREAKAGE. ALSO, WE ARE NOT AWARE OF ANY OTHER COMPLAINTS REGARDING THIS LOT. 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 TWO SCREWDRIVER SHAFTS BROKE OFF. THESE INCIDENTS OCCURRED WHEN ATTEMPTING TO PERFORM THE FINAL TIGHTENING ON THE INNER PART OF THE URS LOCKING CAP, THE SCREWDRIVERS WOULD BREAK ACROSS THE STAR-DRIVE. ON ONE OCCASION, THE STAR-DRIVE SHATTERED AND FRAGMENTS WERE LEFT INSIDE THE LOCKING CAP, WHICH HAD TO BE DISCARDED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262674 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3126319

    Patients

    Seq Age Sex Outcome Treatment
    1