BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 7199041 · Received January 17, 2018

    Report

    Report Number
    1818910-2018-51425
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295216599
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EXAMINATION. 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.

    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

    THE DER STATES THE CAPTURE BLADE IN 86-5034 BROKE DURING PATELLA RESECTION. FEMORAL INTRODUCER/EXTRACTOR BROKE DURING FEMORAL TRIALING. THE BOLT THAT HOLDS IT TOGETHER CAME OUT AND BECAME STRIPPED. NO SURGICAL DELAY. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45924 PFC*CALIBRATED PAT CUT GDE PATELLA HANDLE/CLAMPS HWT DEPUY ORTHOPAEDICS INC US SO2022805 10603295216599

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR