BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SHIM SZ7 6MM

    MDR report key: 16312331 · Received February 7, 2023

    Report

    Report Number
    1818910-2023-03085
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 14, 2023
    Report Date
    February 7, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295133544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL , A FOLLOW-UP WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHIM WAS MISSING ONE OF THE METAL COLLAR INSERTS AND THE ARTICULATING SURFACE HAS SCORING ON THE SPINE WHICH CAN BE FELT DURING TRIALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82281 ATTUNE SHIM SZ7 6MM ATTUNE INSTRUMENTS : TIBIAL TRIALS HWT DEPUY IRELAND - 9616671 2545-00-672 10603295133544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown