BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 7266105 · Received February 13, 2018

    Report

    Report Number
    1818910-2018-53305
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Report Date
    January 29, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    HXC
    UDI-DI
    10603295239789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH 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). EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED EVENT. 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 = NULL. DEVICE HISTORY BATCH = NULL. DEVICE HISTORY REVIEW = NULL. 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

    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.

    Additional Manufacturer Narrative · 1

    PC(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

    961673. LOT SO2008134. -ADAPTER TORQUE WRENCH. THE BLACK PLASTIC ADAPTER THAT POSITIONS OVER THE FEMORAL ADAPTER DETACHED FROM THE INSTRUMENT DURING TIGHTENING.

    Description of Event or Problem · 1

    UPDATE AD (B)(6)2018: THE ISSUE WITH THE ADAPTER TORQUE WRENCH (961673) CAUSED A DELAY OF AROUND 2-3 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109386 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT : TORQUE DEVICES HXC DEPUY ORTHOPAEDICS INC 1818910 SO2008134 10603295239789

    Patients

    Seq Age Sex Outcome Treatment
    1