BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PATELLA COMPRESSION RNG

    MDR report key: 11732439 · Received April 27, 2021

    Report

    Report Number
    1818910-2021-08901
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 12, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWN
    UDI-DI
    10603295395454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: "NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    IT WAS REPORTED THAT THE RUBBER ON PATELLA CLAMP RING IS TORN. NO DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631375 ATTUNE PATELLA COMPRESSION RNG ATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS HWN DEPUY IRELAND - 9616671 2545-01-042 NW151986 10603295395454

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR