BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 52MM

    MDR report key: 4802037 · Received May 28, 2015

    Report

    Report Number
    1818910-2015-22035
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE COMPLAINT. IT IS NOT UNREASONABLE TO EXPECT GRATER HEADS THAT HAVE BEEN IN USE TO NOT BE AS SHARP AS WHEN DISTRIBUTED. TWO OF THE FIVE INSTRUMENTS APPEAR TO HAVE BEEN REPROCESSED BY AN UNAUTHORIZED COMPANY NOT APPROVED BY DEPUY SYNTHES AS INDICATED BY THE LOT NUMBERS. THE OTHER THREE HEADS HAVE THE CORRECT LOT CODES WHICH INDICATE ARE SIX AND SEVEN YEARS OLD. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING BLUNT GREATER HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346636 QUICKSET ACE GRATER HEAD 52MM HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. A0508

    Patients

    Seq Age Sex Outcome Treatment
    1