BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 9577160 · Received January 10, 2020

    Report

    Report Number
    1818910-2020-01486
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Report Date
    December 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295216599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    2 X PFC SIGMA PATELLAR CUTTING GUIDES (865034) WHICH BOTH HAD BROKEN IN THE SAME WAY. THE SAW CAPTURE ON ONE OF THE CLAWS HAD COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40759 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS HWT DEPUY ORTHOPAEDICS INC US 86-5034 NB90459 10603295216599

    Patients

    Seq Age Sex Outcome Treatment
    1