BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, LONG

    MDR report key: 8065577 · Received November 13, 2018

    Report

    Report Number
    1220246-2018-00742
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 13, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225176
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS REQUESTED/IS EXPECTED BUT HAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE AR-9545-T15-03, DRIVER SHAFT, T-15 LONG BROKE IN CENTRAL SCREW HEAD DURING AN RTSA PROCEDURE. DURING THE SAME PROCEDURE, THE REP OPENED A PACKAGE THAT WAS SUPPOSED TO CONTAIN AR-9502F-39RCPC (LOT: 1800369), BUT THERE WAS A 42+6 SPACER INSIDE THE BOX INSTEAD. THE REP CONFIRMED THAT THE 42+6 SPACER WAS NOT USED DURING THE PROCEDURE. THE REP HAD A BACK UP AR-9502F-39RCPC THAT WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/26/2018: THE REP STATED THAT THE TRINITY GUIDE WAS USED FOR THE CENTRAL SCREW. THE SCREW WAS INSERTED INTO THE CENTRAL HOLE CORRECTLY. THE DRIVER WAS USED WITH THE AR-9545-T15H, TORQUE INDICATING ADAPTER. THE REP CONFIRMED THAT THE SURGEON DID NOT EXCEED THE 5MM MARK ON THE TORQUE INDICATING ADAPTER. THE REP CONFIRMED THAT THE TIP OF THE DRIVER REMAINS IN THE HEAD OF THE CENTRAL SCREW. THE REP CONFIRMED THAT THERE NO ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP FROM THE SCREW HEAD. THE CASE WAS COMPLETED BY IMPACTING ENOUGH OF THE SCREW TO MAKE TO CENTRAL CHECKER SHOW GREEN. THE REP CONFIRMED THAT THIS WAS AN INITIAL SURGERY. THE REP CONFIRMED THAT THE ORIGINAL PACKAGING FOR THE MISLABELED AR-9502F-39RCPC (LOT: 1800369) IS AVAILABLE TO RETURN TO ARTHREX. THE REP STATED THAT THE PACKAGE WAS LABELED FOR AN AR-9502F-39RCPC (LOT: 1800369), BUT THE PACKAGE CONTAINED AR-9550-06 (LOT: 17.01630). THE REP STATED THAT THEY HAD TO LEAVE THE OR TO FIND ANOTHER AR-9502F-39RCPC TO USE IN THE PROCEDURE. THE REP STATED THAT THIS ISSUE CAUSED APPROXIMATELY A FIVE TO SEVEN MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904858 DRIVER SHAFT, T-15, LONG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, LONG 8001832 00888867225176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other