BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 38MM

    MDR report key: 7432332 · Received April 16, 2018

    Report

    Report Number
    1818910-2018-57392
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Report Date
    March 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTO
    UDI-DI
    10603295123859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY ORTHOPAEDICS, INC. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL 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

    EVENT: DR. REPORTED THAT THE MILLING CUTTERS BELOW ARE ALREADY WORN AND BLIND DUE TO USE (NATURAL WEAR). DESPITE THIS PROBLEM, THE SURGERY OCCURRED WELL AND NOTHING OF PREJUDICE TO THE SURGICAL ACT. CODE LOT 244000536, SO2017329; 244000537, SO2017428; 244000538, SO2017481; 244000539, SO2017991; 244000540, SO2018302; 244000541, SO2013671; 244000542, SO2011373; 244000543, SO2014494; 244000544, SO2025273; 244000545, SO2017602; 244000546, SO2011857; 244000547, SO2014093; 244000548, SO2013337; 244000549, SO2015991; 244000550, SO2012724; 244000551, SO20154000; 244000552, 9991; 244000553, SO2018039; 244000554, SO2017456; 244000555, SO2015412; 244000556, 9991; 244000557, 9991; 244000558, 9991; 244000559, 9991; 244000560, 9991; 244000561, SO2001627; 244000562, SO2007831; 244000563, 9991; 244000564, SO2012617; 244000565, SO2025863; 244000566, SO2024822; 244000567, SO2023295; 244000568, E4LBW4000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275431 QUICKSET ACE GRATER HEAD 38MM HIP INSTRUMENTS : REAMERS HTO DEPUY ORTHOPAEDICS INC US SO2017481 10603295123859

    Patients

    Seq Age Sex Outcome Treatment
    1