BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 42MM

    MDR report key: 7645166 · Received June 28, 2018

    Report

    Report Number
    1818910-2018-63385
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTO
    UDI-DI
    10603295123897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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: AFTER THE PROCESS OF PRE-WASHING AND STERILIZED THE PRODUCT (DRILL) WERE OXIDIZED. DETAILS OF THE EVENT: THE NEW PRODUCTS ENTERED YESTERDAY ((B)(6) 2018) TO THE (B)(6), WHICH WERE WASHED AND BRUSHED BY HAND ONE BY ONE INSIDE AND OUTSIDE, WITH 10 MINUTES OF SUBMERGED. THIS PROCESS WAS DONE 3 TIMES YESTERDAY. TODAY THEY WERE STEAM STERILIZED AND WHEN THEY CAME OUT THEY HAD SPOTS OF DROPS. THEY WERE SUBMERGED AGAIN WITH ENZYMATIC FOR 10 MINUTES AND WHEN WENT BACK, THEY WERE BRUSHED ONE BY ONE AND WITH A SPONGE AND ALL THE SPOTS WERE REMOVED. AFTER THIS, THEY WAS PUT IN THE PROCESS OF WASHING AND DRYING MACHINE AND FINISHED THIS CYCLE , IT WAS IDENTIFIED THAT THOSE HAVE THE SMALL LASER LETTER WERE OXIDIZED. I DETAIL BELOW THE LIST OF CODE AND LOT OF THEM, ARE 25 IN TOTAL: PRODUCT INFORMATION: (B)(4). AS THE PRODUCT COMPLAINT HAS SEVERAL PRODUCTS (IP), WE REGISTERED 2 COMPLAINTS ((B)(4)) . (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488423 QUICKSET ACE GRATER HEAD 42MM HIP INSTRUMENTS : REAMERS HTO DEPUY ORTHOPAEDICS, INC. 1818910 SO2021809 10603295123897

    Patients

    Seq Age Sex Outcome Treatment
    1