BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 19464089 · Received June 4, 2024

    Report

    Report Number
    1220246-2024-04873
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 7, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    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

    ADDITIONAL INFORMATION: D9, G3, H3, H6 COMPLAINT ALLEGATION IS NOT CONFIRMED. UPON VISUAL INSPECTION, THE FIBERWIRE® #2 BRAIDED POLYBLEND SUTURE, BLUE, W/ TAPERED NEEDLE RETURNED DID NOT HAVE ANY ISSUES WITH THE SUTURES AND/OR NEEDLE ATTACHED. THE BRAID COMPONENT AND NEEDLE PULL TEST PASSED THE REQUIREMENTS PER THE CERTIFICATION RECEIVED FROM THE SUPPLIER AND ARTHREX RECORDS. HOWEVER, THE BROKEN SUTURES/NEEDLES WERE NOT RETURNED, NOR WAS A PHOTOGRAPH PROVIDED FOR A PROPER INVESTIGATION. NO ISSUES WERE FOUND WITH THE PACKAGING MATERIALS. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE DURING SUTURE PASSING, TIGHTENING, OR TENSIONING, AS WELL AS INCORRECT BONE PREPARATION OR CONTACT WITH SHARP INSTRUMENTS DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT, THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150371 FW,BPB #2 SUTR,BLU W/NDL POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL 28038 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown