BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PW BONE FILE

    MDR report key: 10606624 · Received September 30, 2020

    Report

    Report Number
    1818910-2020-21221
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 25, 2020
    Report Date
    September 14, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTP
    UDI-DI
    10603295216520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 RETURNED, THUS THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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

    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

    HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070430 PW BONE FILE KNEE INSTRUMENT : CUTTING INSTRUMENTS HTP DEPUY ORTHOPAEDICS INC US 86-4348 10603295216520

    Patients

    Seq Age Sex Outcome Treatment
    1