BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45 DEG ANGLE DRILL

    MDR report key: 9247576 · Received October 28, 2019

    Report

    Report Number
    1818910-2019-112626
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2019-112489. 1818910-2019-112626 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-112489 WILL BE KEPT FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE DRILL BIT FROM DRIVER SHAFT THE DRILL BIT BROKE OFF INSIDE DRIVER SHAFT. THE DRIVER SHAFT IS NOW USELESS AS A NEW DRILL BIT CANNOT BE INSERTED. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042548 45 DEG ANGLE DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILLS HTW DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1