BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 16MMCORT

    MDR report key: 18725299 · Received February 16, 2024

    Report

    Report Number
    1220246-2024-01011
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    June 30, 2023
    Report Date
    April 15, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047297
    PMA / PMN Number
    K203239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    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 A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 1/18/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2685DR-10 DISTAL CLAVICLE PLATE BROKE EIGHT WEEKS POST-OPERATIVE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR AN OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT COMMINUTED MID-SHIFT CLAVICLE FRACTURE. EIGHT WEEKS LATER, THE PATIENT RETURNED TO THE CLINIC, EXPERIENCING PAINFUL POPS IN THE SHOULDER. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE AR-2685DR-10 DISTAL CLAVICLE PLATE. THE REVISION SURGERY WAS A REVISION OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT CLAVICLE FRACTURE WITH ILIAC BONE GRAFT AND RIGHT CLAVICLE HARDWARE REMOVAL. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/23/2024: DURING THE ORIGINAL PROCEDURE ON (B)(6) 2023, AN AR-2685DR-10 DISTAL CLAVICLE PLATE, AN AR-8827L-20 LOW PROFILE LOCKING SCREW, (4) AR-8827L-18 LOW PROFILE LOCKING SCREW, (2) AR-8835-16 LOW PROFILE SCREW, AN AR-8835-18 LOW PROFILE SCREW, (2) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW WERE IMPLANTED. DURING THE REVISION SURGERY ON (B)(6) 2023, ALL THE IMPLANTS WERE SUCCESSFULLY REMOVED. THE REVISION SURGERY WAS COMPLETED USING AN AR-2653CR CLAVICLE FRACTURE PLATE, (3) AR-8835-18 LOW PROFILE SCREW, (3) AR-8835L-18 LOW PROFILE LOCKING SCREW, AND AN AR-8835L-16 LOW PROFILE LOCKING SCREW. BOTH PROCEDURES WERE COMPLETED AT THE SAME FACILITY AND BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530134 LO-PRO SCRW TM,SS 3.5X 16MMCORT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT UNK 00888867047297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other