BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 3902010 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02314
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OSTEOTOMY THE END PIECE OF THE BLADE BROKE WHEN USED CLOSE TO THE CREGO RETRACTOR. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OSTEOTOMY, THE END PIECE OF THE BLADE BROKE WHEN USED CLOSE TO THE CREGO RETRACTOR. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380978 UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNKNOWN GFA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) LOT UNKNOWN