BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE

    MDR report key: 5983323 · Received September 28, 2016

    Report

    Report Number
    1220246-2016-00399
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 2, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. NO DEVICE MALFUNCTION IDENTIFIED. AT THIS TIME, IT CANNOT BE DETERMINED IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. COMPLAINANT'S EVENT TYPICALLY CAUSED BY CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, TORQUING WHILE LEVERAGING THE DEVICE AND/OR USING THE INCORRECT SCREW WITH THE DRIVER (SCREW DOES NOT SEAT FULLY ON THE DRIVER). THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TALONAVICULAR FRACTURE PROCEDURE THERE WAS AN ISSUE WITH TWO AR-8737-38 T10 HEXALOBE DRIVERS, BOTH LOT NUMBERS 4751424. THE TIP OF THE FIRST HEXALOBE DRIVER BROKE OFF IN THE AR-8740-34H LOT 1270548 COMPRESSION FT SCREW. IT WAS REMOVED FROM THE SCREW AND THE SECOND HEXALOBE DRIVER WAS PUT INTO THE SAME SCREW TO ADVANCE IT. THE SECOND DRIVER TIP ALSO BROKE OFF IN THE SCREW. THE SURGEON HAD TO USE AN OSTEOTOME TO CREATE SPACE IN THE PATIENT'S BONE AROUND THE SCREW TO HELP GET THE SCREW LOOSE TO BE ABLE TO ALLOW USE OF PLIERS TO REMOVE THE SCREW. THE SCREW WAS REMOVED. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND A 4.0 CANNULATED SMALL FRAGMENT SCREW WAS USED TO COMPLETE THE CASE. PATIENT (B)(6) MALE WITH HARD BONE. BOTH OF THE HEXALOBE DRIVERS ARE BEING RETURNED FOR EVALUATION. THE SCREW WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634204 T10 HEXALOBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 4751424 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other