BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 4212330 · Received October 30, 2014

    Report

    Report Number
    0001811755-2014-03835
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE CUTTING ACCESSORY ORIGINALLY REPORTED UNDER THIS MDR WAS NOT RETURNED FOR EVALUATION. DURING THE EVALUATION OF THE ORIGINALLY LISTED CONCOMITANT DEVICE ((B)(4) LOT 13296, SD/PD MEDIUM CURVED ATTACHMENT), AN ISSUE WITH THE ATTACHMENT WAS OBSERVED BY WAY OF A TIP BEARING SHATTERED WHICH PREVENTS A BUR FROM BEING INSERTED INTO THE ATTACHMENT. ASSOCIATED CUTTING ACCESSORY (UNKNOWN INS BUR, UNKNOWN LOT #) IS NOW LISTED AS THE CONCOMITANT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE OFF IN THE ATTACHMENT. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE OFF IN THE ATTACHMENT. THERE WAS NO PATIENT IMPACT OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694934 SD/PD MEDIUM CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 13296

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) LOT 13296| UNKNOWN_INSTRUMENTS BUR, UNKNOWN LOT ID