BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTR ANCH,BIO-COMP S-TAK

    MDR report key: 20990420 · Received December 20, 2024

    Report

    Report Number
    1220246-2024-08995
    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. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, SUTURETAK, AR-1934BCF-2, BATCH 15303856, WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE ANCHOR WAS BROKEN OFF FROM THE DEVICE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO IMPROPER BONE PREPARATION OR PRYING/LEVERAGING THE SCREW DURING INSERTION. PER DFU-0054-EO; REVISION 5: AVOID EXCESSIVE IMPACTION DURING ANCHOR INSERTION AS THIS COULD LEAD TO INSERTER DAMAGE AND/OR BREAKAGE. IF INSERTION RESISTANCE IS ENCOUNTERED, DO NOT IMPACT HARDER. REPLACE THE IMPLANT AND REPEAT THE DRILLING/INSERTION PROCESS.

    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
    2168989 SUTR ANCH,BIO-COMP S-TAK NON-DEGRADABLE FIXATN FASTENER MAI ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK 15303856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown