BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP SYSTEM HANDLE

    MDR report key: 12598968 · Received October 8, 2021

    Report

    Report Number
    1818910-2021-22442
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 29, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295084174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 BEREVIEWED 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.

    Description of Event or Problem · 0

    B. PLEASE CONFIRM IF THE INSTRUMENT WAS USED DURING SURGERY. IF YES, WAS SURGERY TIME EXTENDED? IT WAS USED IN SURGERY SUCCESSFULLY. UNABLE TO DETACH POST OP BY SSD. C. WHAT WAS THE DURATION OF THE DELAY? NO DELAY. D. LOT NUMBER: SIGMA HP SYSTEM HANDLE (202499111). SIGMA HP SYSTEM HANDLE (202499111). I WAS NOT SENT THE LOT NUMBERS I AM AFRAID.

    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

    MOVEMENT PART OF HANDLE WILL NOT DISENGAGE. ON BOTH HANDLES THE THEY ARE STUCK IN THE ENGAGED POSITION AND CANNOT BE UNSTUCK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498683 SIGMA HP SYSTEM HANDLE KNEE INSTRUMENT : HANDLES LXH DEPUY ORTHOPAEDICS INC US 2024-99-111 10603295084174

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown