BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, LONG

    MDR report key: 7873456 · Received September 13, 2018

    Report

    Report Number
    1220246-2018-00644
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 13, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225176
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP WAS BROKEN-OFF WHICH WAS NOT ORIGINALLY REPORTED AND WAS ONLY DISCOVERED DURING THE EVALUATION PROCESS. THE HEX WAS ALSO TWISTED. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE CONTINUALLY APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, TORQUING WHILE LEVERAGING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING INSERTION OF THE CENTRAL SCREW THE TIP OF THE AR-9545-T15-03 (LOT: 8001643), LONG DRIVER SHAFT SKIPPED OUT OF THE SCREW HEAD. THIS OCCURRED DURING A LEFT REVERSE TOTAL PROCEDURE. A SECOND AR-9545-T15-03 (LOT: 8001721) WAS BROUGHT IN, BUT THE SAME ISSUE OCCURRED. A THIRD AR-9545-T15-03(LOT: 8001549) WAS USED TO COMPLETE THE PROCEDURE IN A NORMAL MANNER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 08/17/2018: THE LOT NUMBERS OF THE DEVICES HAVE BEEN PROVIDED. THE REP STATED THAT DURING THE PROCEDURE THE SURGEON MENTIONED THAT THE DRIVER TIP DID NOT SEEM TO FULLY INSERT INTO THE SCREW HEAD CAVITY. UPON FINAL TORQUE, THE DRIVER TIP WOULD JUMP OUT OF THE SCREW. THE REP STATED THAT THE SURGEON CONTINUED TO REMARK THAT THE DRIVER TIP DID NOT WANT TO FULLY ENGAGE THE SCREW HEAD. ADDITIONAL INFORMATION RECEIVED ON 08/30/2018: THE REP RECONFIRMED THAT THE TIP ON THE AR-9545-T15-03 (LOT: 8001643) BROKE WHILE INSERTING THE CENTRAL SCREW AND THE BROKEN PIECE WAS RETRIEVED FROM THE SCREW HEAD WITH A FRASIER SUCTION TIP AND DENTAL PICK. THE BROKEN TIP WAS THEN DISCARDED. THE REP RECONFIRMED THAT THE AR-9545-T15-03 (LOT: 8001721) WAS DROPPED ON THE FLOOR IN CENTRAL STERILE PRIOR TO THE CASE STARTING. THE REP STATED THAT THEY ARE NOT ABLE TO CONFIRM IF THERE WAS ANY DAMAGE RELATED DURING OR FROM THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712851 DRIVER SHAFT, T-15, LONG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, LONG 8001721 00888867225176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other