BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PW BONE FILE

    MDR report key: 8041292 · Received November 6, 2018

    Report

    Report Number
    1818910-2018-74600
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    February 28, 2018
    Report Date
    November 5, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTP
    UDI-DI
    10603295216520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED BLUNT CONDITION. 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. 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

    BONE FILE REPORTED TO BE BLUNT BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880813 PW BONE FILE KNEE INSTRUMENT : CUTTING INSTRUMENTS HTP DEPUY ORTHOPAEDICS INC US A0402 10603295216520

    Patients

    Seq Age Sex Outcome Treatment
    1