BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS TORQUE LIMITING T-HANDLE 55 IN.-LBS.

    MDR report key: 1982742 · Received February 9, 2011

    Report

    Report Number
    1825034-2011-00074
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1825034-01/28/2011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DECISION WAS MADE TO RECALL THE PRODUCT. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, AS THE SURGEON WAS REAMING THE FEMORAL CANAL, THE TABS ON THE T-HANDLE FRACTURED. THERE WAS NO DELAY IN THE SURGERY AND NO FOREIGN BODIES WERE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCOS TORQUE LIMITING T-HANDLE 55 IN.-LBS. INSTRUMENT, MANUAL MDM BIOMET ORTHOPEDICS N/A 419402

    Patients

    Seq Age Sex Outcome Treatment
    1