BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.55MM X 10MM FLUTED TWIST DRL

    MDR report key: 3173303 · Received June 17, 2013

    Report

    Report Number
    1045834-2013-02474
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 27, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL INSPECTION OF THIS DEVICE WAS PERFORMED UNDER 10X MAGNIFICATION. THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THAT THE CUTTER WAS EXPOSED TO EXCESSIVE LATERAL FORCE DURING USE. THE S-1510TD IS A TWIST DRILL AND IS DESIGNED FOR PLUNGE CUTTING HOLES ONLY. THE FLUTES ARE NOT DESIGNED FOR SIDE CUTTING AND WILL FRACTURE WHEN THIS IS ATTEMPTED, AS DEMONSTRATED HERE. THIS DEVICE MET ALL DIMENSIONAL SPECIFICATIONS. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM SURGICAL PROCEDURE THE CUTTER/BUR DEVICE "BROKE IN TWO PIECES". ACCORDING TO THE REPORT, THE SURGEON ATTACHED THE CUTTER/BUR DEVICE INTO THE ATTACHMENT DEVICE. WHEN THE SURGEON ATTEMPTED TO DRILL THE BONE, IT WAS OBSERVED THAT THE CUTTER/BUR DEVICE BROKE IN TWO PIECES. NONE OF THE DEVICE PIECES BROKE INSIDE THE PATIENT'S BODY. A SPARE ATTACHMENT DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO DELAYS REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274446 1.55MM X 10MM FLUTED TWIST DRL MOTOR, DRILL, ELECTRIC - CUTTER/BUR HBC DEPUY SYNTHES POWER TOOLS F533073547

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT| HAND PIECE