BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 L46 F/NAILS TAN LIGHT GREEN

    MDR report key: 2803090 · Received October 24, 2012

    Report

    Report Number
    8030965-2012-01131
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 24, 2012
    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

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE RAW MATERIAL PAPERS WERE REVIEWED AND MET SPECIFICATIONS. ALL FEATURES THAT COULD BE MEASURED WERE IN SPECIFICATION. AN EXACT CAUSE COULD NOT BE FOUND. THERE WAS NO PRODUCT OR MATERIAL FAULT WAS FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING INSERTION OF A SSFN TIBIAL NAIL THE SURGEON WAS USING THE AIMING DEVICE AND THE 5.0MM LOCKING SCREWS WERE HITTING THE NAIL. THE SURGEON THEN PLACED 4.0MM LOCKING SCREWS IN THE PROXIMAL HOLES OF THE NAIL. THE NAIL WAS SUCCESSFULLY IMPLANTED AND PATIENT IS REPORTEDLY DOING WELL. THIS REPORT IS #1 OF 6 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKSCR Ø5 L46 F/NAILS TAN LIGHT GREEN LOCKSCR Ø5 L46 F/NAILS TAN LIGHT GREEN HWC SYNTHES GMBH 7616114

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS, NAIL