BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEM SIZING & FINISH

    MDR report key: 11393599 · Received March 1, 2021

    Report

    Report Number
    1818910-2021-04031
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 17, 2021
    Report Date
    February 17, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    FSM
    UDI-DI
    10603295423539
    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: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED, THUS THE REPORTED EVENT COULD NOT BE CONFIRMED. 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.

    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 SIZING AND FINISHING PAN HAS THE PLASTIC PIECES PEELING OFF WHERE THE ANGEL WING AND PATELLA DRILL SIT AND CAN¿T READ THE PICTURES ON THE BOTTOM FOR DESCRIPTIONS. THE RP IMPACTORS ARE CRACKED AND GETTING READY TO BREAK APART. THE 5/6 SHIM IS CRACKED IN THE MIDDLE. THE 3 RP ART SURFACE IS CRACKED ON THE BOTTOM. THESE ITEMS WERE ALL FOUND IN THE SETS AND NOT USED IN SURGERY. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288307 ATTUNE FEM SIZING & FINISH ATTUNE INSTRUMENTS : INSTRUMENT CASES FSM DEPUY IRELAND - 9616671 2545-01-703 10603295423539

    Patients

    Seq Age Sex Outcome Treatment
    1