BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 8526668 · Received April 18, 2019

    Report

    Report Number
    1220246-2019-01057
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867127166
    PMA / PMN Number
    K150456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP TO REFLECT A CHANGE OF PART NUMBER FROM THE ORIGINAL SUBMISSION.THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT 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 DURING KNEE ABLATION, HARDWARE REMOVAL SCREW AR-8740-36H, THE FIRST SCREWDRIVER SHAFT AR-8737-38 BROKE. THE SECOND TEST WAS TRIED WITH A SECOND SCREWDRIVER WITH SAME PART NUMBER, WHICH BROKE TOO. THIRD TEST WAS WITH ANOTHER MANUFACTURER'S SCREWDRIVER WHICH BROKE ALSO. DRILLING THE SCREW, THERE WAS DEPOSIT OF TITANIUM FILINGS IN THE TISSUES SUBCUTANEOUS. IT WAS NOT RETRIEVED. IT REMAINS IN PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 12-APR-2019: BATCH NUMBER OF SCREW IS 1391608. SURGEON TOOK ANOTHER MANUFACTURER'S DRILL AND DRILLED THE SCREW HEAD BECAUSE THERE WERE SOME FRAGMENTS. BECAUSE OF DRILLING, THE HEAD OF SCREW BROKE AND REMAINED IN PATIENT. SURGEON WAS NOT ABLE TO REMOVE THE SCREW BECAUSE IT IS TOO SMALL. THERE WAS NO ABRASION, ONLY FRAGMENTS OF SCREW REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320210 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HRS ARTHREX, INC. AR-8740-36H 1391608 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other