BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 7376039 · Received March 27, 2018

    Report

    Report Number
    1219602-2018-00378
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 1, 2018
    Report Date
    April 26, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010446114
    PMA / PMN Number
    K925573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOREIGN ZIP CODE: (B)(6).

    Additional Manufacturer Narrative · 1

    ONE 014771 T-FIX RCG STERILE PAC 2MM STERILE T FIX RCG DRILL WITH HUB RETURNED. THE COMPLAINT STATES: ¿IT WAS REPORTED THAT THE T-FIX WAS READY TO BE USED, PLUGGED ON THE POWER TOOL. THE T-FIX BROKE AT FULL SPEED, ENTERING THE CORACOID PROCESS. THE TIP OF THE MALE PART BROKE, JUST UNDER THE CONNECTION OF MALE/FEMALE PARTS. BROKEN PIECE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE.¿ THERE ARE SCRATCHES AND DINGS ON THE BLADE FLUTES. THE DRILL SHAFT IS SLIGHTLY BOWED AND HAS SPIRAL WEAR BANDS. THERE ARE ALSO RANDOM SCRATCHES IN OTHER LOCATIONS. THE DRILL¿S TAIL PORTION HAS BEEN FRACTURED FROM OVER TORQUE AT THE LOCATION WHERE THE 2MM DRILL HUB IS PERMANENTLY ATTACHED. PER THE IFU: ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE.¿ NO ROOT CAUSE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE WAS ESTABLISHED. NO FURTHER INVESTIGATION WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE T-FIX WAS READY TO BE USED, PLUGGED ON THE POWER TOOL. THE T-FIX BROKE AT FULL SPEED, ENTERING THE CORACOID PROCESS. THE TIP OF THE MALE PART BROKE, JUST UNDER THE CONNECTION OF MALE/FEMALE PARTS. BROKEN PIECE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215998 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 014771 50677114 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1