BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM FLUTED DRILL W/ DEPTH STOP

    MDR report key: 3880186 · Received June 18, 2014

    Report

    Report Number
    1219602-2014-00180
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS CONFIRMED THAT THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MARKED AS AVAILABLE FOR EVALUATION IN SECTION D10; ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    DURING A BANKART REPAIR PROCEDURE UTILIZING A 2.5MM FLUTED DRILL W/ DEPTH STOP, IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE DRILLING. THE BROKEN PART OF THE DEVICE REMAINED IN THE SITE AND WILL NOT BE REMOVED FROM THE PATIENT. THE MISSING PIECE WAS NOTICED AFTER THE INSERTION AND KNOT TYING OF A SMITH & NEPHEW OSTEORAPTOR 2.3MM SUTURE ANCHOR. THE PATIENT¿S BONE QUALITY WAS NORMAL. THIS DEVICE HAS BEEN PREVIOUSLY USED APPROXIMATELY 120 TIMES. THE DEVICE WAS STERILIZED WITH THE AUTOCLAVE STERILIZATION AT 134°C. AN UNKNOWN MANUFACTURER'S POWER INSTRUMENT WAS USED WITH THE DEVICE. THERE WERE NO REPORTS OF PATIENT INJURIES OR PAIN POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357970 2.5MM FLUTED DRILL W/ DEPTH STOP 2.5MM FLUTED DRILL W/ DEPTH STOP NBH MANSFIELD MANUFACTURING SITE 72202890 50373080

    Patients

    Seq Age Sex Outcome Treatment
    1