BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREW, BIO-INTERFERENCE, 8 X 23 MM

    MDR report key: 1001410 · Received February 20, 2008

    Report

    Report Number
    1220246-2008-00019
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    December 20, 2007
    Report Date
    January 29, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THE IMPLANT BROKE APPROX IN HALF. REVIEW OF THE DEVICE HISTORY REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART /LOT COMBINATION. THE COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY IMPROPER BONE PREPARATION (HOLE TOO SMALL) RESULTING IN THE NEED TO APPLY EXCESSIVE TWISTING FORCE AND LEVERAGING. THIS EVENT WAS ATTRIBUTED TO MISUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BROKE DURING SURGERY AND A PIECE OF THE IMPLANT REMAINS IN THE PT. THE CUSTOMER HAS NOT REPORTED ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER PT INFO IS AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, BIO-INTERFERENCE, 8 X 23 MM BIO-ABSORBABLE IMPLANT MAI ARTHREX, INC. NA 123340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other