BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 8807181 · Received July 19, 2019

    Report

    Report Number
    1220246-2019-01209
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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 VIA FDA MEDWATCH ((B)(4)) THAT A FACILITY REPORTED THAT DURING A CANNULATED SCREW REMOVAL PROCEDURE THE FOLLOWING OCCURRED: WHILE ATTEMPTING TO REMOVE A CANNULATED SCREW FROM THE PATIENT'S RIGHT HEEL WITH A CANNULATED SCREWDRIVER, AR-8737-38, THE DOCTOR BROKE A PIECE OF THE SCREWDRIVER HEAD OFF IN THE SCREW THAT WAS STILL IN THE PATIENT. THE REPORT LISTED DATE OF SURGERY AS (B)(6) 2019 WITH NO SPECIFIC DATE. THE REPORT RECEIVED DID NOT SPECIFY THE REASON FOR THE CANNULATED SCREW REMOVAL PROCEDURE, DATE OF AN ORIGINAL IMPLANT SURGERY PROCEDURE, OR WHETHER THE SCREW WAS ACTUALLY EXPLANTED. UPDATE 7/19/19: THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE FACILITY MEDWATCH REPORTER WITH NO RESPONSE RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602928 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT UNK 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other