BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW,TI,3.5MMX 22MM

    MDR report key: 20146596 · Received September 5, 2024

    Report

    Report Number
    1220246-2024-07384
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    May 3, 2024
    Report Date
    July 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050488
    PMA / PMN Number
    K203294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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: E4, G3, H3, H6, H10 THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE PROVIDED INFORMATION, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR. THIS INCLUDES IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING OR LEVERING THE DEVICE DURING INSERTION, WHICH RESULTED IN THE DEVICE BREAKING/ AND OR DAMAGED. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE, WHERE THE DEVICES ARE DISPLAYED AND THE LOW PROFILE SCREW IS SHOWN WITH DAMAGE TO THE SCREW'S HEAD.

    Description of Event or Problem · 0

    ON 8/12/2024, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT A CANCELLOUS COMPRESSION SCREW, BEING USED WITH A TROCAR TIP TO STABILIZE A LISFRANC INJURY, BROKE OFF IN THE FOOT. THE BROKEN FRAGMENTS WERE NOT REMOVED. ON (B)(6) 2024, THE PATIENT REPORTED THAT THE PROCEDURE TOOK PLACE ON (B)(6) 2024 IN WHICH AN AR-8935CL-26 KREULOCK COMPRESSION SCREW, AN AR-8935-22 NON-LOCKING LOW PROFILE SCREW, AN AR-8935CL-32 KREULOCK COMPRESSION SCREW, AND AN AR-8951MR MEDIUM RIGHT LISFRANC PLATE WAS IMPLANTED. ADDITIONALLY, ANOTHER PLATE AND 5 SCREWS WITH UNKNOWN PART NUMBERS WERE ALSO IMPLANTED. DURING THE PROCEDURE, ONE OF THE SCREWS BROKE ABOUT THE FIFTH THREAD DOWN. AT THIS TIME, IT IS UNKNOWN WHICH SCREW BROKE. THE SURGEON DECIDED TO LEAVE THE BROKEN FRAGMENT IN THE PATIENT, AS REMOVING IT WOULD CAUSE MORE HARM. ONCE THE PATIENT WAS HEALED, ON (B)(6) 2024, A SECOND PROCEDURE WAS PERFORMED TO REMOVE BOTH PLATES AND EIGHT SCREWS, EXCEPT THE BODY OF THE PREVIOUSLY BROKEN SCREW. THE PART NUMBER FOR THE TROCAR TIP REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042932 LO-PRO SCRW,TI,3.5MMX 22MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 22MM 15110232 00888867050488

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other