BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL INTRODUCER

    MDR report key: 9029590 · Received September 13, 2019

    Report

    Report Number
    1818910-2019-104384
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWR
    UDI-DI
    10603295130215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. CORRECTED: CONCOMITANT MEDICAL PRODUCTS AND DEVICE EVALUATED BY MFR. PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED BREAKAGE. THE INVESTIGATION DID NOT INDICATE THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 RED PLASTIC CLIP ON SIDE OF FEMORAL INTRODUCER BROKE OFF WHEN IMPACTING FEMUR. IT BROKE OFF IN ONE WHOLE PIECE. PIECE LANDED ON THE FLOOR AND WAS THROWN AWAY BY OR STAFF. NO PIECES LANDED IN THE PATIENT. THIS DID NOT DELAY SURGERY. SURGEON DOES NOT WISH TO BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821973 ATTUNE FEMORAL INTRODUCER ATTUNE INSTRUMENTS : INSERTION DEVICES HWR DEPUY IRELAND - 9616671 ABC10731 10603295130215

    Patients

    Seq Age Sex Outcome Treatment
    1