BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1982740 · Received February 9, 2011

    Report

    Report Number
    1825034-2011-00091
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    RES 57915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6) 2011, WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND THE USER FACILITY REPORT REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER, AND EVENT. THIS REPORT FILED FEBRUARY 23, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE DOCTOR WAS USING A T-HANDLE TO LOCK THE DISTAL STEM TO THE PROXIMAL BODY AT THE BACK TABLE. AS THE SURGEON WAS DRIVING IN THE LOCKING SCREW, THE TABS ON THE T-HANDLE FRACTURED. NO PATIENT INJURY OR DELAY IN THE PROCEDURE WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, THE DOCTOR WAS USING A T-HANDLE TO LOCK THE DISTAL STEM TO THE PROXIMAL BODY AT THE BACK TABLE. AS THE SURGEON WAS DRIVING IN A LOCKING SCREW, THE TABS ON THE T-HANDLE FRACTURED. NO PATIENT INJURY OR DELAY IN THE PROCEDURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1