BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE FUSION PLATE, LATERAL TTC

    MDR report key: 10309706 · Received July 22, 2020

    Report

    Report Number
    1220246-2020-01969
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    July 10, 2020
    Report Date
    September 3, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867134010
    PMA / PMN Number
    K141735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE PLATE WAS FOUND TO BE BROKEN IN TWO. THE DEVICE AND SCREWS RETURNED EXHIBITED SURFACE DAMAGE THAT LIKELY OCCURRED DURING REMOVAL. NO BENDING DEFORMATION WAS OBSERVED ON THE PLATE. REVIEW OF THE DEVICES AND X-RAY PROVIDED SUGGEST A LIKELY CAUSE OF THE EVENT IS NON-UNION OF THE JOINT.

    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 THE PATIENT HAD AN ANKLE FUSION ON (B)(6) 2019 AND THE PATIENT EXPERIENCED PAIN AND SWELLING HAD A FOLLOW UP X-RAY AT THE END OF (B)(6) THAT REVEALED THE AR-8970TTC, ANKLE FUSION PLATE, WAS BROKEN. LOT NUMBER OF THE PLATE WAS UNKNOWN AT THE TIME OF INITIAL REPORT. THE PATIENT HAD TO WAIT UNTIL JUNE TO HAVE A REVISION SURGERY TO REMOVE THE BROKEN PLATE AND SCREWS. THE DOCTOR USED A REVISION ANKLE SUBTALAR FUSION TO REMEDY THE SITUATION. THE PATIENT IS CURRENTLY IN A CAST AND IN A HEALING STATE. ADDITIONAL INFORMATION OBTAINED 7/20/2020: THE ORIGINAL PROCEDURE WAS A TTC FUSION ON (B)(6) 2019. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020. THE REVISION WAS COMPLETED USING A NAIL. THE SURGEON HAS THE PLATE AND SCREWS AND WILL RETURN THEM TO ARTHREX FOR EVALUATION. THE PATIENT SUFFERED NO KNOWN TRAUMA SINCE THE ORIGINAL PROCEDURE. BOTH ORIGINAL AND REVISION PROCEDURES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY. SCREW PART NUMBERS ARE NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION OBTAINED 7/21/2020: THE FOLLOWING ARE THE DEVICES ORIGINALLY IMPLANTED (B)(6) 2019. THE SURGEON CHOSE TO REMOVE ALL OF THE BELOW DEVICES DURING THE REVISION SURGERY: AR-8970TTC, ANKLE FUSION PLATE LATERAL, LOT 6791444. AR-8545-40, LOW PROFILE SCREW, LOT 10184335. AR-8545-44, LOW PROFILE SCREW, LOT 10265231. AR-8545L-24, LOW PROFILE LOCKING SCREW, LOT 1050683. AR-8545L-28, LOW PROFILE LOCKING SCREW, LOT 1042333. AR-8545L-30, LOW PROFILE LOCKING SCREW, LOT 1051302. AR-8545L-32, LOW PROFILE LOCKING SCREW, LOT 1014160. AR-8545L-38, LOW PROFILE LOCKING SCREW, LOT 1050682. AR-8967-1840, LOW PROFILE SCREW, LOT 031739. AR-8970-09, LARGE BB-TAK, LOT 819784873. AR-8970-09, LARGE BB-TAK, LOT 900849548. AR-8970-09T, LARGE BB-TAK THREADED, LOT 021443.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775848 ANKLE FUSION PLATE, LATERAL TTC PLATE, FIXATION, BONE HRS ARTHREX, INC. ANKLE FUSION PLATE, LATERAL TTC 6791444 00888867134010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other