BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 SELF-TAP L85 TAN

    MDR report key: 3231235 · Received July 17, 2013

    Report

    Report Number
    8030965-2013-04375
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 25, 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS WITH POWDER WHICH WAS DESCRIBED IN THE DEVICE REPORT WAS SHAVED OFF THE PACKAGE. THROUGHOUT THE TRANSPORT OF THIS SCREW, THE SCREW HEAD WITH THE THREAD WAS SLIGHTLY MOVING AND SHAVING OFF THE INSIDE SURFACE OF THE PACKAGE. THE DEVICE HISTORY RECORD WAS RESEARCHED FOR THE LISTED ARTICLE; NO ABNORMAL FINDINGS WERE IDENTIFIED. THIS OCCURRENCE MUST HAVE HAPPENED DURING THE TRANSPORT. THIS SCREW CAN GET CLEANED AND RE STERILIZED IF SUCH PROBLEMS DO OCCUR IN THE FUTURE. WE ARE AWARE OF THAT PROBLEM AND WILL TRY TO LOOK INTO A BETTER SOLUTION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A HIGH TIBIAL OSTEOTOMY ON (B)(6) 2013, THE SURGEON OPENED THIS PRODUCT, AND FOUND A WHITE POWDER ON THE IMPLANT. REPORTEDLY, THE SURGEON AND THE STAFF OF THE OPERATION ROOM RECOGNIZED IT WAS A DEFECTIVE PRODUCT, SO THEY USED ANOTHER ONE AND WENT ON WITH THE OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330585 LOCKSCR Ø5 SELF-TAP L85 TAN KTT SYNTHES GMBH 2401309

    Patients

    Seq Age Sex Outcome Treatment
    1