BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN

    MDR report key: 3090556 · Received May 2, 2013

    Report

    Report Number
    8030965-2013-02091
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K000089
    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 DOCUMENTS 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MICROSCOPIC INVESTIGATION SHOWS THAT THE SCREW CAME IN CONTACT WITH ANOTHER METALLIC PART. THE THREAD IS WORN AND DAMAGED AT THE RUN IN. THE LOCKING SCREW WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL LOCK OF AN EXPERT TIBIAL NAIL (ETN), THE 34MM 5.0 LOCKING SCREW WAS INSERTED. THE LENGTH WAS CHECKED UNDER AN IMAGE INTENSIFIER AND IT WAS TOO LONG. THE SURGEON DECIDED TO REMOVE IT. AFTER THE SCREW WAS REMOVED, IT WAS REPORTED THAT THE SCREW THREAD WAS COMING OFF OF THE SCREW. THE SURGEON BELIEVED THAT NO SCREW THREAD WAS LEFT IN PATIENT, AS NOTHING WAS SHOWN IN IMAGE INTENSIFIER. ANOTHER SCREW WAS AVAILABLE AND IMPLANTED INTO THE PATIENT SUCCESSFULLY. NO PATIENT IMPACT OR DELAY OF SURGERY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192121 LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN HWC SYNTHES GMBH 8200330

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR