BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3193206 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03784
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    April 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE TIPS OF THE INSTRUMENTS WERE BROKEN WHEN THE SURGEON DID THE FINAL TIGHTENING. THE PRESENT SCREWDRIVERS WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AND NO ABNORMALITIES WERE IDENTIFIED. THE FRACTURED SURFACES ARE HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE CAUSE AND NO PRODUCT OR MATERIAL RELATED CONDITION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE INSTRUMENTS WERE BROKEN WHEN THE SURGEON DID THE FINAL TIGHTENING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294449 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3144650

    Patients

    Seq Age Sex Outcome Treatment
    1