BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTR ANCH,BIO-COMP S-TAK

    MDR report key: 20990317 · Received December 20, 2024

    Report

    Report Number
    1220246-2024-08993
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 26, 2024
    Report Date
    March 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K140855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKED AR-1934BCF-2 SUTR ANCH, BIO-COMP S-TAK SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION OF THE SHAFT AND HANDLE DID NOT REVEAL ANY DAMAGE. THE EVALUATION OF THE SUTURE AND THE ANCHOR/BIO FOUND NO DAMAGE TO THE SUTURE; HOWEVER, THE EVALUATION OF THE ANCHOR/BIO REVEALED A CRACK, DAMAGE TO THE THREAD¿S GEOMETRY, AND A MISSING PIECE AT THE DISTAL END OF THE SCREW. FUNCTIONAL TESTING WAS PERFORMED BY PULLING THE SUTURES TO CHECK FOR RESISTANCE AND FUNCTIONALITY. NO PROBLEMS WERE FOUND. THE MOST LIKELY CAUSE OF THE REPORTED AND OBSERVED FAILURE IS USER ERROR, SPECIFICALLY IMPROPER BONE PREPARATION AND/OR MISALIGNMENT DURING INSERTION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE ANCHORS ARE BREAKING OFF WHILE INSERTING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 20-DEC-2024 FURTHER INFORMATION RECEIVED WITH THE INCOMING DELIVERY DOCUMENT. IT WAS REPORTED THAT THE ANCHOR DID NOT HOLD IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151603 SUTR ANCH,BIO-COMP S-TAK NON-DEGRADABLE FIXATN FASTENER MAI ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK 15281731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown