BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT F/LOCKCAP F/URS

    MDR report key: 3193274 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04056
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    November 30, 2011
    Report Date
    January 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    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 MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND. THE INVESTIGATION OF THE COMPLAIN INSTRUMENTS HAS SHOWS THAT THE TIP OF THE DRIVER IS INDEED BROKEN OFF. THE STRUCTURE OF THE BROKEN SURFACE INDICATES THAT TOO MUCH APPLIED MECHANICAL FORCE HAS LEAD TO THIS DAMAGE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE SUPPOSE THAT A MECHANICAL OVERLOAD BY APPLYING TOO MUCH LATERAL STRESS CAUSED THIS BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER SHAFT IS BROKEN OFF. DURING THE FINAL TIGHTENING OF AN URS LOCKING CAP, THE TIP OF THE SCREWDRIVER SHAFT FOR LOCKING CAP BROKE OFF. ONE FRAGMENT FELL INTO THE PATIENT, BUT COULD BE RECOVERED AFTER SOME TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294611 SCRDRIVERSHAFT F/LOCKCAP F/URS HXX SYNTHES GMBH 3436684

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR