BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 18352174 · Received December 18, 2023

    Report

    Report Number
    1220246-2023-09476
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    May 4, 2023
    Report Date
    February 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO PATIENT SPECIFIC EVENT. DIRECTION FOR USE. DFU-0110 COMPRESSION SCREWS. D. ADVERSE EFFECTS. 1. INFECTIONS, BOTH DEEP AND SUPERFICIAL. 2. FOREIGN BODY REACTIONS. 3. NON-HEALING DUE TO INADEQUATE BLOOD SUPPLY IN THE AREA OF THE REPAIR. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE DOCUMENTATION PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6), 2023, IT WAS REPORTED BY THE SURGEON THAT HIS PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE DEVICES AND/OR INSTRUMENTS USED IN A PRIOR SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6), 2023, MEDICAL RECORDS WERE PROVIDED CONFIRMING THAT THE SURGEON PERFORMED A BUNIONECTOMY, AND 1ST METATARSAL OSTEOTOMY OF THE LEFT FOOT WAS PERFORMED ON (B)(6), 2020. ARTHREX¿S SALES RECORDS FOR THE PATIENT¿S DECEMBER 2020 PROCEDURE INDICATE THE SCREWS IMPLANTED DURING THE SURGERY WERE ARTHREX¿S AR-8725-24H COMPR FT SCRW,2.5 MICRO,24MM LGTH (LOT 10546665), AR-8730-28H COMPR FT SCRW,3.5 MINI,28MM LGTH (LOT 10279485) AND AR-8730-36H COMPR FT SCRW,3.5 MINI, 36MM (LOT 10443285). FOLLOWING THE INITIAL SURGERY, THE RECORDS INDICATE THAT ON (B)(6), 2023, A SECOND SURGERY WAS PERFORMED BY THE SAME SURGEON TO REMOVE A PROMINENT SCREW IN THE 1ST LEFT METATARSAL. DURING THIS SURGERY, MULTIPLE ARTHREX INSTRUMENTS WERE USED TO ATTEMPT TO REMOVE THE SCREW HOWEVER THE PROCEDURE WAS ABANDONED AS THE SCREW WAS UNABLE TO BE REMOVED FROM THE BONE AFTER MULTIPLE ATTEMPTS WITH DIFFERENT REMOVAL INSTRUMENTS. ALL SCREWS REMAIN IMPLANTED. THOSE INSTRUMENTS HAVE BEEN IDENTIFIED AS ARTHREX¿S AR-8737-35 DRILL BIT STRAIGHT CANNULATED 2.7 M, AR-8737-38 DRIVER, CANNULATED T10 HEXALOBE AND AR-8737-61 SCREW EXTRACTOR MINI. THE SURGEON HAS REQUESTED INFORMATION RELATED TO THE DEVICES AS THE PATIENT IS EXPERIENCING ALLERGIC TYPE REACTIONS. SPECIFICALLY, AN AREA WITH A SMALL MACULAR PAPULAR RASH MEDIAL ASPECT LEFT FIRST RAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298422 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT UNK 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Other