BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LABRALTAPE, WHITE 1.5MM 36"

    MDR report key: 8389937 · Received March 5, 2019

    Report

    Report Number
    1220246-2019-00933
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    September 10, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041936
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 THAT THE PATIENT UNDERWENT A LUNATE-SCAPHOID COMPLETE TEAR REPAIR PROCEDURE ON (B)(6) 2018 WHEN AN ARTHREX DEVICE WAS USED TO REPAIR A LIGAMENT TEAR IN HIS LEFT WRIST. HOLES WERE DRILLED INTO HIS WRIST BONES AND ONE IN THE RADIUS. ACCORDING TO THE PATIENT THE PROCEDURE FAILED AND HE NOW HAS TO UNDERGO ANOTHER SURGERY TO REMOVE THE DEVICES AND HIS WRIST BONES. PATIENT FURTHER STATES THAT A CT SCAN SHOWED DEGRADATION OF THE HOLES DRILLED FOR THE ARTHREX IMPLANT. THE SECOND SURGERY WILL TAKE PLACE ON (B)(6) 2019. THE PATIENT BELIEVES IT WOULD BE BENEFICIAL TO HAVE A REPRESENTATIVE PRESENT DURING SURGERY TO DETERMINE POST OP ON WHY THE INITIAL OPERATION HAD ISSUE. ADDITIONAL INFORMATION OBTAINED 1/18/2019: UPON REQUEST FOR ADDITIONAL INFORMATION THE PATIENT RESPONDED THAT HE WAS JUST GIVING ARTHREX A HEADS UP ABOUT HIS SITUATION BUT DOES NOT WANT TO GO THROUGH THE EFFORT TO OBTAIN/PROVIDE THE INFORMATION/DOCUMENTS THAT ARTHREX HAS REQUESTED. HE WILL ASK HIS CURRENT SURGEON TO PROVIDE HIS OPINION UPON REVISION TAKING PLACE AND WILL LET ARTHREX KNOW THE OUTCOME. NO PART NUMBERS HAVE BEEN PROVIDED TO DATE FROM THE ORIGINAL PROCEDURE. ADDITIONAL INFORMATION OBTAINED 1/22/2019: REVISION PROCEDURE WILL TAKE PLACE ON (B)(6) 2019 AT A DIFFERENT FACILITY THAN THE ORIGINAL PROCEDURE. ADDITIONAL INFORMATION OBTAINED 2/11/2019: THE FOLLOWING ARE THE PART NUMBERS THAT WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2018 PROCEDURE: AR-8978P, DX SWIVELOCK SL, (LOT F201171). AR-8978P, DX SWIVELOCK SL, (LOT 10185859). AR-7276, LABRALTAPE, (LOT S705658). AR-7232-02 2-0, FIBERWIRE LOOP, (LOT 17901). THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019 DURING WHICH TIME THE ORIGINAL DEVICES WERE EXPLANTED. DURING THE REVISION THE SURGEON REMOVED THE PROXIMAL ROW OF BONES AND INSERTED AN ALLOGRAFT. ONE ANCHOR IS BEING RETURNED FOR EVALUATION AND THE SECOND ANCHOR WAS SENT TO FACILITY LAB FOR TESTING. RESULTS ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183428 LABRALTAPE, WHITE 1.5MM 36" SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. LABRALTAPE, WHITE 1.5MM 36" S705658 00888867041936

    Patients

    Seq Age Sex Outcome Treatment
    1 Other