BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL T-HANDLE

    MDR report key: 8621070 · Received May 17, 2019

    Report

    Report Number
    1818910-2019-93911
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    UDI-DI
    10603295079941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. PRODUCT COMPLAINT(B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY= EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE WAS SHOWN TO BE SPLIT AFTER SURGERY. NO PIECES WERE BROKEN OFF OR MISSING. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413082 EXCEL T-HANDLE HIP INSTRUMENTS : HANDLES LXH DEPUY ORTHOPAEDICS, INC. 1818910 SO2032557 10603295079941

    Patients

    Seq Age Sex Outcome Treatment
    1