BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR Ø4 L20/8 SST

    MDR report key: 2840471 · Received November 20, 2012

    Report

    Report Number
    8030965-2012-01299
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    PREAMENDMENT
    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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED ARTICLE SHOWS THAT THERE IS A FOREIGN PIECE IN THE SCREW HEAD. THROUGHOUT THE PROCESS OF WHIRL GRINDING, A PIECE OF THE GRINDING STONE JAMMED UP INSIDE THE STAR DRIVE. UNFORTUNATELY THIS FAILURE GOT NOT DISCOVERED BY THE FINAL INSPECTION OF THIS LOT. THIS SCREW WAS MANUFACTURED IN 2008. IN 2009 THE PROCESS OF WHIRL GRINDING GOT REMOVED OUT OF THE MANUFACTURING ORDER FOR THIS KIND OF SCREW. WE CLASSIFY THIS AS AN INDIVIDUAL CASE.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE DISCOVERY BY A SURGEON OF FOREIGN METAL IN A SCREW HEAD RECESS, PRIOR TO THE USE OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUSSCR Ø4 L20/8 SST CANCELLOUS SCREW HWC SYNTHES GMBH 2336796

    Patients

    Seq Age Sex Outcome Treatment
    1