BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE

    MDR report key: 6060473 · Received October 27, 2016

    Report

    Report Number
    1220246-2016-00456
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2016-00455 (CC97995 LINE 172898). 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 IS TYPICALLY CAUSED BY 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 FIRST 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.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS THE SECOND OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2016-00455 ((B)(4)). 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. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT THE RETURNED DEVICE'S DISTAL TIP WAS BROKEN OFF. THE FRACTURE SURFACE DISPLAYS EVIDENCE OF TORSIONAL-OVERLOAD. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. COMPLAINT EVENT MOST LIKELY DUE TO THE HARDNESS OF THE BONE EXCEEDING THE TORSIONAL STRENGTH OF THE DRIVER. THIS IS THE FIRST 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 TWO HEXALOBE T10 DRIVERS WERE BEING USED IN A LARGE MID-FOOT FUSION CASE WITH DELTOID RECONSTRUCTION AND A T-N FUSION PROCEDURE. A 4.0MM COMPRESSION FT SCREW WAS INSERTED BY WAY OF A 3.2MM DRILL BIT, AND WAS IMPLANTED CORRECTLY OVER A 1.1MM GUIDE WIRE. THE POSITION OF THE SCREW WAS NOT WHAT WAS DESIRED BY THE SURGEON, SO THE SURGEON ATTEMPTED TO REVERSE THE SCREW OUT USING A HEXALOBE T10 DRIVER AR-8737-38 LOT 4751451 (CC97995 LINE 172898). WHEN HE PLACED THE DRIVER BACK OVER THE GUIDE WIRE AND ATTEMPTED TO REVERSE THE SCREW OUT, THE TIP OF THE DRIVER BROKE INTO PIECES. THE BROKEN PIECES WERE RETRIEVED. THE SECOND HEXALOBE T10 DRIVER LOT 4751438 (CC97995 LINE 172900) WAS ATTEMPTED AND THE SAME EVENT HAPPENED. THOSE BROKEN PIECES WERE RETRIEVED AS WELL. THE INCISION HAD TO BE OPENED MORE TO REMOVE ALL METAL FRAGMENTS THAT HAD BROKEN-OFF FROM THE DRIVERS. A SOLID T10 DRIVER WAS USED TO REMOVE THE SCREW SUCCESSFULLY. THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO HEXALOBE T10 DRIVERS WERE BEING USED IN A LARGE MID-FOOT FUSION CASE WITH DELTOID RECONSTRUCTION AND A T-N FUSION PROCEDURE. A 4.0 MM COMPRESSION FT SCREW WAS INSERTED BY WAY OF A 3.2 MM DRILL BIT, AND WAS IMPLANTED CORRECTLY OVER A 1.1 MM GUIDE WIRE. THE POSITION OF THE SCREW WAS NOT WHAT WAS DESIRED BY THE SURGEON, SO THE SURGEON ATTEMPTED TO REVERSE THE SCREW OUT USING A HEXALOBE T10 DRIVER AR-8737-38 LOT 4751451 ((B)(4)). WHEN HE PLACED THE DRIVER BACK OVER THE GUIDE WIRE AND ATTEMPTED TO REVERSE THE SCREW OUT, THE TIP OF THE DRIVER BROKE INTO PIECES. THE BROKEN PIECES WERE RETRIEVED. THE SECOND HEXALOBE T10 DRIVER LOT 4751438 ((B)(4)) WAS ATTEMPTED AND THE SAME EVENT HAPPENED. THOSE BROKEN PIECES WERE RETRIEVED AS WELL. THE INCISION HAD TO BE OPENED MORE TO REMOVE ALL METAL FRAGMENTS THAT HAD BROKEN-OFF FROM THE DRIVERS. A SOLID T10 DRIVER WAS USED TO REMOVE THE SCREW SUCCESSFULLY. THE CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710635 T10 HEXALOBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 4751438 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other