BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM

    MDR report key: 23135200 · Received September 24, 2025

    Report

    Report Number
    1220246-2025-04113
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS THE ANCHOR, THE EYELET, AND THE SUTURES DID NOT HAVE ANY VISUAL ISSUES. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. PER PICTURES EVALUATION NO PROBLEM WAS FOUND WITH THE IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR BROKE DURING INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 12-SEP-2025 THE DEVICE WON`T BE RETURNED AS IT REMAINED INSIDE THE PATIENT. UPDATE AVOE 13-SEP-2025 IT WAS CONFIRMED THAT THE FAILURE OCCURRED DURING A ROTATOR CUFF REPAIR SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430617 BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM 15403351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown