BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM CARBIDE FLUTED BALL, STANDARD

    MDR report key: 3970133 · Received July 31, 2014

    Report

    Report Number
    1045834-2014-12538
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    - THE TYPE OF PRODUCT INVOLVED WAS INITIALLY REPORTED INCORRECTLY BY THE FACILITY, AND HAS BEEN UPDATED TO REFLECT THE CORRECT COMPONENT. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS CONFIRMED. A VISUAL AND DIMENSIONAL ASSESSMENT WAS PERFORMED WHICH DETERMINED THAT THE DEVICE MET ALL MEASURABLE DIMENSION SPECIFICATIONS. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE EXCESSIVE SIDE LOADING OF THE DEVICE DURING USE, WHICH IS MISUSE, ABUSE AND/OR USER ERROR. 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

    THE LOT NUMBER WAS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURE WAS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BROKEN PIECE OF THE DEVICE WITH NO INJURIES TO THE PATIENT. 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
    446923 6MM CARBIDE FLUTED BALL, STANDARD DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED) HBC DEPUY SYNTHES POWER TOOLS H053090058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention