BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT D2.5 X 170 MM

    MDR report key: 10450079 · Received August 25, 2020

    Report

    Report Number
    1818910-2020-18730
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 12, 2020
    Report Date
    August 14, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HTW
    UDI-DI
    10603295116547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (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

    DURING AN ORTHOPEDIC PROCEDURE OB (B)(6) 2020, A BLUNT DRILL BIT WAS REPORTED. THE DRILL BIT WAS DISCARDED AND ANOTHER BIT WAS USED TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915996 DRILL BIT D2.5 X 170 MM DRILLS (BITS, SLEEVES, GUIDES) : DRILLS HTW DEPUY FRANCE SAS - 3003895575 2307-90-005 10603295116547

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR