BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL IMPACTOR

    MDR report key: 15073045 · Received July 21, 2022

    Report

    Report Number
    1818910-2022-13611
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 21, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE CANNOT CONFIRM THE REPORTED ALLEGATION, HOWEVER THE DEVICE WAS FOUND BROKEN INSTEAD. THE BROKEN PARTS WERE NOT RETURNED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. LOT WAS ADDED # AU7581271, UPDATE THE (B)(4), DECONTAMINATION STATUS, ANALYSIS SITE TO JRZ COMPLAINTS, QTY CHANGED FROM 0 TO 1 THE DEVICE WAS RECEIVED AT PAL JRZ. 30/MAY/2022. 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FEMORAL IMPACTOR IS CRACKED. FOUND UPON INSPECTION AFTER CASE. NO SURGICAL DELAY DUE TO THIS EVENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719767 ATTUNE FEMORAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-006 AU7581271 10603295130222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown