BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 SELF-TAP L55 TAN

    MDR report key: 3054266 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-01566
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IMPLANT DATE REPORTED AS EARLY 2012. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRO CODE: HWC. THE SCREW HEAD WAS FALLEN OFF THE SHAFT. WE ASSUME THAT THIS OCCURRED DUE APPLYING OF TOO MUCH TORQUE ON TO THE SCREW HEAD. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. ENTERED IN ERROR: 510K NUMBER SHOULD BE K000682.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IN EARLY 2012, PATIENT WAS IMPLANTED WITH TOMOFIX DURING HIGH TIBIAL OSTEOTOMY. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR HARDWARE REMOVAL. DURING EXPLANT, AS SURGEON WAS REMOVING THE SCREW AT HOLE D, THE SCREW HEAD BROKE. SCREW AND BROKEN HEAD WERE RETRIEVED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156878 LOCKSCR Ø5 SELF-TAP L55 TAN KTT SYNTHES GMBH 2758988

    Patients

    Seq Age Sex Outcome Treatment
    1