BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø2.4 SELF-TAP L20 TAN

    MDR report key: 3141324 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02591
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 22, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MEASURABLE DIMENSIONS OF THE BROKEN SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATION. THE VISUAL INSPECTION REVEALED THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATIONS. IT IS POSSIBLE THAT MECHANICAL OVERLOADING MAY HAVE CAUSED THE BREAKAGE OF THE SCREW HEAD. NO PRODUCT FAULT COULD BE DETECTED... AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE, WE CAN ONLY ASSUME THAT MECHANICAL OVERLOADING DUE TO INSUFFICIENT BONE HEALING OR REMOVAL PROCEDURE MAY HAVE CAUSED THE BREAKAGE. THE COMPLAINT HAS BEEN DETERMINED TO BE INVALID. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    THE SCREW WAS FOUND BROKEN DURING REMOVAL SURGERY. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245051 LOCKSCR Ø2.4 SELF-TAP L20 TAN HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR