BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PW BONE FILE

    MDR report key: 10606629 · Received September 30, 2020

    Report

    Report Number
    1818910-2020-21223
    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: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED DULL CONDITION. THE NOTED WEAR IS CONSISTENT WITH DEVICE USE FROM NORMAL USE AND SERVICING AND THE INVESTIGATION DID NOT ESTABLISH A NEED FOR CORRECTIVE ACTION. 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. H10 ADDITIONAL NARRATIVE: ADDED: D4 (LOT), D10, H4; CORRECTED: H3.

    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
    1070816 PW BONE FILE KNEE INSTRUMENT : CUTTING INSTRUMENTS HTP DEPUY ORTHOPAEDICS INC US 86-4348 A1000 10603295216520

    Patients

    Seq Age Sex Outcome Treatment
    1