BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL BLADE

    MDR report key: 4111802 · Received September 23, 2014

    Report

    Report Number
    0001811755-2014-03342
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURN HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET MADE AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    THE CAST CUTTER BLADE ASSOCIATED WITH THIS EVENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THERE WAS NO EXCESSIVE WEAR ON THE TEETH THAT ALL TEETH WERE INTACT. FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE CAST CUTTER WAS BEING USED TO CUT SYNTHETIC MATERIAL. THE IFU (INSTRUCTIONS FOR USE) FOR THE CAST CUTTER BLADE CAUTIONS THE USER THAT THE STAINLESS STEEL CAST CUTTER BLADES ARE NOT RECOMMENDED FOR USE WITH SYNTHETIC MATERIAL. THE USE OF THIS CAST CUTTER BLADE WITH SYNTHETIC MATERIAL MAY HAVE MADE THE BLADE APPEAR TO BE DULL WHEN IN USE WITH SUCH CUTTING MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED INITIALLY REPORTED THAT THE BLADE BROKE AFTER BEING USED 10 TIMES. IT WAS SUBSEQUENTLY REPORTED THAT THE BLADE WAS BLUNT. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE AFTER BEING USED 10 TIMES. THERE WERE NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590096 STAINLESS STEEL BLADE INSTRUMENT, CAST REMOVAL, AC-POWERED LGH STRYKER INSTRUMENTS-KALAMAZOO 14168017

    Patients

    Seq Age Sex Outcome Treatment
    1