BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP INTERFSCRW W/DISP SHTH

    MDR report key: 23209023 · Received October 3, 2025

    Report

    Report Number
    1220246-2025-04384
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    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 UNPACKAGED AR-1380C BIOCOMPOSITE INTERFERENCE SCREW, WITH DISPOSABLE SHEATH, 8 X 23 MM BATCH 14916940 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SCREW¿S THREAD PROFILE WAS BROKEN OFF. ADDITIONALLY, WARPING WAS NOTED AT THE TIP OF THE SCREW. NO DAMAGE WAS OBSERVED ON THE CANNULA. FUNCTIONAL TESTING CANNOT BE PERFORMED AS THE DEVICE WAS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER BONE PREPARATION AND INCORRECT SURGICAL TECHNIQUE DURING DEVICE APPLICATION. THESE FACTORS MAY HAVE CONTRIBUTED TO THE MALFUNCTION OR COMPROMISED THE INTEGRITY OF THE IMPLANT DURING THE PROCEDURE. THE SCREW WAS OAL WAS MEASUREMENT ACCORDING TO DRAWING C2422 AT REVISION 4 COMPONENT C2422-03: .906+.010/-.015 INCHES. RESULT: 0.546 INCHES. THE SCREW IS SHORTER DUE TO BREAKAGE.

    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 AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE. THE SUTURE WAS FIXATED WITH THE DEVICE AR-1380C. THE SCREW BROKE DURING INSERTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623073 BIO-COMP INTERFSCRW W/DISP SHTH BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH 14916940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown