BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 22090193 · Received May 27, 2025

    Report

    Report Number
    1220246-2025-02218
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    January 9, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: B5, D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. -UPON VISUAL INSPECTION, THE THREADS OF THE LOW-PROFILE LOCKING SCREW¿, 2.7 X 14 MM, WERE DAMAGED. THE SINGLE-USE DEVICE WAS USED/REMOVED AND RETURNED FOR INVESTIGATION DUE TO THE DEVELOPMENT OF PSEUDARTHROSIS AT THE FRACTURE SITE. DIMENSIONAL INSPECTION WAS CONDUCTED IN ACCORDANCE WITH DRAWING C1330-03, AND ALL MEASURED VALUES WERE FOUND TO BE WITHIN SPECIFIED TOLERANCES. (REFER TO DIMENSION RESULTS FOR DETAILS.) FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT SPECIFIED. PER DFU-0125-EO G. PRECAUTIONS - 4. DAMAGE TO THE DRIVER OR SCREW MAY RESULT FROM FAILURE TO SEAT THE DRIVER FULLY INTO THE SCREW OR TO ALIGN THE DRIVER PROPERLY WITH THE SCREW. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR, SPECIFICALLY DUE TO MISALIGNED INSERTION OR MISALIGNMENT DURING THE SCREW REMOVAL PROCESS. THIS MAY HAVE INTRODUCED UNINTENDED STRESS OR DAMAGE TO THE IMPLANT COMPONENTS. A SECONDARY, RELATED FAILURE MODE INVOLVES THE DEVELOPMENT OF PSEUDARTHROSIS AT THE FRACTURE SITE, WHICH LIKELY CONTRIBUTED TO PROLONGED INSTABILITY AND DELAYED HEALING. THIS CONDITION MAY HAVE INCREASED MECHANICAL STRESS ON THE IMPLANT, ULTIMATELY LEADING TO HARDWARE FATIGUE AND BREAKAGE, AND RESULTING IN ADVERSE PATIENT OUTCOMES FOR REVISION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE CONTEXT OF A PSEUDARTHROSIS OF A LATERAL MALLEOLAR FRACTURE THE IMPLANTED PLATE BROKE APPROXIMATELY 1 YEAR POSTOPERATIVE. IT WAS FURTHER REPORTED THAT THE FRACTURE OF THE PATIENT DID NOT HEAL AFTER ONE YEAR AND THEREFORE A PSEUDARTHROSIS WAS DIAGNOSED. IT WAS ALSO REPORTED THAT THE BREAKAGE OF THE PLATE DID NOT OCCUR EARLY, AS THE PLATE WAS 9 MONTHS AFTER THE IMPLANTATION STILL INTACT. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW 23-MAY-2025: FURTHER INFORMATION WAS PROVIDED THAT THE SCREW WAS EXPLANTED.

    Description of Event or Problem · 0

    ***UPDATE DW 04-JUN-2025: IN TOTAL 15 DEVICES WERE RETURNED TO ARTHREX FOR THE REPORTED CASE. TWO PLATES, 12 SCREWS AND ON TIGHTROPE. NO FURTHER INFORMATION ABOUT AN ALLEGATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013774 UNK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other