BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø7X 20MM BC IF SCRW, VENTED

    MDR report key: 21048398 · Received December 31, 2024

    Report

    Report Number
    1220246-2024-09150
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    October 13, 2024
    Report Date
    August 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867276956
    PMA / PMN Number
    K202535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW CRACKED WHEN BEING INSERTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 05-DEC-2024. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SURGERY. UPDATE AVOE 16-DEC-2024. IT WAS FURTHER REPORTED THAT THE SURGEON USED THE DEVICE IN AN ANTERIOR CRUCIATE LIGAMENT SURGERY WITH DIDT. THE SURGEON WAS USED TO THE OLD BIOCOMPOSITE INTERFERENCE SCREWS, WHICH HAD A MUCH SMALLER THREAD PITCH THAN THE FASTTHREADS. HE WAS THEREFORE USED TO HAVING TO USE MORE FORCE TO LOWER THE SCREW. NO PATIENTS OR OTHER THIRD PARTIES WERE INJURED DURING SCREW BREAKAGE. THE REPORTED BREAKAGE OCCURRED WHEN THE SCREW WAS INSERTED INTO THE PATIENT'S LARGE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847065 Ø7X 20MM BC IF SCRW, VENTED BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. Ø7X 20MM BC IF SCRW, VENTED 15254492 00888867276956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown