BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 8649287 · Received May 29, 2019

    Report

    Report Number
    1220246-2019-01113
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    501

    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 DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. 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 DURING A REVISION TRICEP REPAIR PROCEDURE, IT WAS DISCOVERED THAT THERE WAS ABNORMAL CELLULAR GROWTH AND PATHOLOGIES AROUND THE SITE WHERE THE IMPLANTED SUTURES (AR-7200, FIBERWIRE) WERE LOCATED. THE REP STATED IT IS UNKNOWN THE REASON FOR THE REVISION PROCEDURE. THE CONSTRUCT WAS COMPROMISED, AND THERE WAS AN INFECTIOUS REACTION FOUND INTERNALLY. THE REP STATED THERE WAS NOT A REPORT OF THE PATIENT EXPERIENCING TOPICAL REACTIONS PRIOR TO HAVING THE REVISION DONE. THE REP STATED THEY WERE NOT MADE AWARE OF THE SPECIFIC PART NUMBERS THAT WERE IMPLANTED DURING THE PRIMARY PROCEDURE. HOWEVER, THE SURGEON DID STATE THEIR CONCERN WAS WITH THE AR-7200 FIBERWIRE THAT WAS USED TO HOLD THE ANCHORS IN PLACE. THE SURGEON REMOVED THE IMPLANTED AR-7200 DURING THE REVISION PROCEDURE, BUT THE METAL CORKSCREWS REMAINED IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 05/28/2019: THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL DISTAL TRICEPS REPAIR PROCEDURE THAT TOOK PLACE ON (B)(6) 2018: AR-1928SNF-2 // LOT: 10156887, AR-7200 // LOT: UNKNOWN. THE INITIAL AND REVISION PROCEDURE WERE PERFORMED BY TWO DIFFERENT SURGEONS AT DIFFERENT FACILITIES. THE PATIENT STARTED HAVING COMPLAINTS OF MILD PAIN ON (B)(6) 2018, BUT NEVER RETURNED TO THE ORIGINAL SURGEON. THE PATIENT WENT TO THE SECOND SURGEON IN (B)(6) 2018 TO OBTAIN A SECOND OPINION. THE REVISION PROCEDURE WAS THEN PERFORMED ON (B)(6) 2019. CULTURES WERE TAKEN INTRAOPERATIVELY AND CANDIDA PARAPSILOSIS WAS CONFIRMED IN THE JOINT FLUID BUT NOT THE TISSUE. THERE WERE NOT ANY ADDITIONAL ARTHREX PARTS IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED FIBERWIRE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442515 FW,BPB #2 SUTR,BLU W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL UNK 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other