BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.55MM X 10MM FLUTED TWIST DRL

    MDR report key: 6033512 · Received October 17, 2016

    Report

    Report Number
    1045834-2016-12954
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K113476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). PLEASE NOTE THAT THE INCORRECT COMMON DEVICE NAME, AND DEVICE PRODUCT CODE WERE INADVERTENTLY ENTERED INTO THE INITIAL MEDWATCH REPORT. THE CORRECT INFORMATION HAS BEEN UPDATED IN THIS SUPPLEMENTAL REPORT. PLEASE NOTE THAT THE INCORRECT CATALOG NUMBER (S-1510TD) WAS ENTERED INTO THE INITIAL REPORT. THE CORRECT CATALOG NUMBER (S-1510TD-G1) HAS BEEN RECEIVED AND ENTERED INTO THIS SUPPLEMENTAL REPORT. THE LOT NUMBER WAS REPORTED AS UNKNOWN IN THE INITIAL REPORT. THE LOT NUMBER (K053113837) HAS BEEN RECEIVED AND ENTERED INTO THIS SUPPLEMENTAL REPORT. THE PMA/510(K) NUMBER WAS INADVERTENTLY ENTERED INTO THE INITIAL REPORT AS K011444. THE CORRECT PMA/510(K) NUMBER (K113476) HAS BEEN ENTERED INTO THIS SUPPLEMENTAL MEDWATCH REPORT. THE PREVIOUS REPORT STATED THE DATE OF MANUFACTURE (DOM) WAS UNKNOWN. THE DOM HAS BEEN UPDATED TO REFLECT THE DATE (B)(4) 2016 THE DEVICE WAS MANUFACTURED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION THAT THE DEVICE HAD A BROKEN TIP WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED ON THE EXTERNAL FEATURES OF THE RETURNED CUTTER AND OBSERVED THAT THE TIP OF THE CUTTER WAS BROKEN. THE CUTTER WAS EXAMINED AND PHOTOGRAPHED USING 40X MAGNIFICATION. IT WAS NOTED THAT, BASED ON THE PHOTOGRAPHS TAKEN, THE ANGLE INDICATE THAT THERE WAS EXCESSIVE FORCE APPLIED. IT WAS DETERMINED THAT THE ROOT CAUSE OF THE ¿CUTTERS BROKE¿ WAS EXCESSIVE LATERAL OR SIDE TO SIDE FORCE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE COMPONENT DAMAGE CAUSED BY USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT WHILE MAKING A SUTURE HOLE DURING A TENTING PROCEDURE, IT WAS OBSERVED THAT THE CUTTING BURR DEVICE BROKE. IT WAS REPORTED THAT AN IDENTICAL SPARE DEVICE WAS USED AND THIS DEVICE ALSO BROKE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE. IT WAS NOT REPORTED IF AN ADDITIONAL SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT NO FRAGMENTS/PARTS OF THE DEVICE FELL IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    686895 1.55MM X 10MM FLUTED TWIST DRL DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS K053113837

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTING BURR DEVICE