BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP INTERFSCRW,FULL THD

    MDR report key: 17929138 · Received October 13, 2023

    Report

    Report Number
    1220246-2023-08179
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 18, 2023
    Report Date
    July 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867015357
    PMA / PMN Number
    K071176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1380TC/ BATCH 14968933 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DEVICE WAS BROKEN, AND THE THREADS OF THE DEVICE WERE DAMAGED. THE LENGTH OF THE DEVICE WAS MEASURED WITH CALIPER 1003729 AND FOUND THAT THE DIMENSION WAS 1.115, WHICH WERE NOT WITHIN TOLERANCE OF THE SPECIFIED 1.102± .010. THIS IS DUE TO THE DAMAGE OF THE DISTAL END OF THE SCREW WHICH HAS WARPED SOME OF THE THREADS. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED ON THE RETURNED AR-4020C-06 DUE TO THE DAMAGE TO THE DEVICE. THE METHOD USED TO PREPARE THE BONE SOCKET, AS WELL AS THE BONE QUALITY ENCOUNTERED, WERE NOT PROVIDED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED MISUSE DUE TO IMPROPER BONE PREPARATION; MISALIGNED INSERTION; OR PRYING/LEVERAGING THE SCREW DURING INSERTION.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW COULD NOT BE TIGHTENED / HAD BECOME LOOSE. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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
    1969297 BIO-COMP INTERFSCRW,FULL THD BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP INTERFSCRW,FULL THD 14968933 00888867015357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown