BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø2.4 SELF-TAP L24 TAN

    MDR report key: 3171584 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03257
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    October 19, 2011
    Report Date
    October 27, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE MEASURABLE DIMENSIONS OF THE SCREW WERE, AS FAR AS POSSIBLE, CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS WAS NOT POSSIBLE SINCE WE ARE NOT AWARE OF THE CONCERNED LOT NUMBERS. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE IS HOMOGENOUS AND DOES NOT SHOW ANY ANOMOLIES. NO PRODUCT FAULT COULD BE DETECTED. THERE IS EVIDENCE THAT A MECHANICAL OVERLOAD DURING THE REMOVAL, PAR EXAMPLE BY A COLD WELDED THREAD OR AN EXCESSIVE CONTACT BETWEEN THE SCREW AND THE PLATE, CAUSED THE BREAKAGE OF THE SCREW. THE EXACT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2011, THE SCREW BROKE DURING REMOVAL. THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272441 LOCKSCR Ø2.4 SELF-TAP L24 TAN HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR