BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 4221403 · Received November 3, 2014

    Report

    Report Number
    0001811755-2014-03915
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL BLADE AND THE HANDPIECE SAW (6206000000, SN (B)(4)) SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKE. NO FURTHER DEVICE INSPECTION WAS POSSIBLE AS THE BLADE COULD NOT BE REMOVED FROM THE SAW HEAD ASSEMBLY. BASED ON REVIEW OF THE INFORMATION PROVIDED IN RELATION TO THIS REPORTED EVENT AND AS DEVICE INSPECTION OF THE AFFECTED PRODUCT IS NOT POSSIBLE, THE ROOT CAUSE OF THIS EVENT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF A BLADE BROKE IN THE HANDPIECE. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF A BLADE BROKE IN THE HANDPIECE. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701113 UNKNOWN_INSTRUMENTS_PRODUCT BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 6206000000, SN (B)(4)| 6206000000, SERIAL (B)(4)