BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 48MM

    MDR report key: 12289104 · Received August 6, 2021

    Report

    Report Number
    1818910-2021-17353
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 27, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTO
    UDI-DI
    10603295123958
    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). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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

    IT WAS REPORTED THAT THESE INSTRUMENTS ARE BLUNT DUE TO WEAR AND TEAR AND NEED REPLACING. THIS COMPLAINT CAPTURES IMPACTED PRODUCTS 121-136 OF MAIN COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186157 QUICKSET ACE GRATER HEAD 48MM HIP INSTRUMENTS : REAMERS HTO DEPUY ORTHOPAEDICS INC US 2440-00-548 10603295123958

    Patients

    Seq Age Sex Outcome Treatment
    1