BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC* MOD PLUS TORQUE DRIVER

    MDR report key: 7304309 · Received February 28, 2018

    Report

    Report Number
    1818910-2018-54313
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Report Date
    January 29, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    HWR
    UDI-DI
    10603295215868
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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

    (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

    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

    THE FOLLOWING INSTRUMENTS DIDN¿T FUNCTION CORRECTLY DURING KNEE REVISION SURGERY. THE 860284. LOT UNKNOWN -PFC MOD PLUS TORQUE DRIVER DIDN¿T APPEAR TO CLICK AT MAXIMUM TORQUE CAUSING THE WOBBLE BITS TO FRACTURE. THE 961673. LOT SO2008134. -ADAPTER TORQUE WRENCH. THE BLACK PLASTIC ADAPTER THAT POSITIONS OVER THE FEMORAL ADAPTER DETACHED FROM THE INSTRUMENT DURING TIGHTENING. THE 217863136. LOT TBJGF. - MODIFIED HUDSON ADAPTER GOT STUCK ON ONE OF THE MBT REAMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148179 PFC* MOD PLUS TORQUE DRIVER SCREWDRIVERS HWR DEPUY ORTHOPAEDICS INC 1818910 NI 10603295215868

    Patients

    Seq Age Sex Outcome Treatment
    1