BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT F/LOCKCAP F/URS

    MDR report key: 3022686 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-10600
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    April 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). PLACEHOLDER.

    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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICES WERE RETURNED AND INVESTIGATION SHOWED THAT THE INSTRUMENTS BROKE DUE TO A MECHANICAL OVERLOADING. THE FRACTURE SURFACES SHOWED NO IRREGULARITIES. EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH, AND STRUCTURAL STABILITY. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED, ALTHOUGH A POSSIBLE CAUSE IS RELATED TO THE TORQUE LIMITER. MATERIAL AND MANUFACTURING RELATED CONDITIONS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL TIP OF BOTH SCREWDRIVER SHAFTS BROKE OFF DURING INSERTION OF THE LOCKING CAPS. THE BROKEN FRAGMENTS WERE RETRIEVED. A T-HANDLE WITH RATCHET WRENCH AND TORQUE LIMITER WAS USED AND THE LOCKING CAPS WERE POSITIONED AND TIGHTENED AS REQUIRED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125101 SCRDRIVERSHAFT F/LOCKCAP F/URS HXX SYNTHES GMBH 3072578

    Patients

    Seq Age Sex Outcome Treatment
    1