BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45 DEG ANGLE DRILL

    MDR report key: 10792289 · Received November 5, 2020

    Report

    Report Number
    1818910-2020-24008
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 21, 2020
    Report Date
    October 21, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTW
    UDI-DI
    10603295120179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CANNOT CONFIRM THE COMPLAINT. DEPUY-SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    WE RECEIVED A NEW ANGLED DRILL YESTERDAY ON PO 915185 (LOT SO2050903) AND IT SEEMS TO BE GRINDING WHEN TURNED AND MDR SAID THAT THERE WERE METAL SHAVINGS COMING OUT OF THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259940 45 DEG ANGLE DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILLS HTW DEPUY ORTHOPAEDICS INC US 2366-83-000 SO2050903 10603295120179

    Patients

    Seq Age Sex Outcome Treatment
    1