BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC* MOD PLUS TORQUE DRIVER

    MDR report key: 7266088 · Received February 13, 2018

    Report

    Report Number
    1818910-2018-53304
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Report Date
    January 29, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    HWR
    UDI-DI
    10603295215868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT. 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.

    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

    860284. LOT UNKNOWN -PFC MOD PLUS TORQUE DRIVER DIDN¿T APPEAR TO CLICK AT MAXIMUM TORQUE CAUSING THE WOBBLE BITS TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109179 PFC* MOD PLUS TORQUE DRIVER KNEE INSTRUMENT : SCREWDRIVERS HWR DEPUY ORTHOPAEDICS INC 1818910 SW0614 10603295215868

    Patients

    Seq Age Sex Outcome Treatment
    1