BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW TM,SS 3.5X 16MMCORT

    MDR report key: 14675312 · Received June 13, 2022

    Report

    Report Number
    1220246-2022-05071
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047297
    PMA / PMN Number
    K203239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    COMPLAINT NOT CONFIRMED. UPON VISUAL INSPECTION IT WAS NOTED THAT THERE WAS SLIGHT WEAR TO THE THREADS AND THE HEXALOBE. THE DAMAGE TO THE THREADS AND HEXALOBE CAN MOST LIKELY BE CONTRIBUTED TO IMPLANTATION/EXPLANATION OF THE DEVICE. MEASUREMENT OF THE DEVICE SHOWS THAT THE DEVICES MEET DESIGN SPECIFICATIONS. NO ALLEGATION WAS MADE AGAINST THIS DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2652CR CLAVICLE FRACTURE PLATE WAS IMPLANTED IN PATIENT ON (B)(6) 2022 DURING A CLAVICLE FRACTURE. PATIENT FELT THE PLATE BREAK AND ON (B)(6) 2022, IT WAS CONFIRM VIA X-RAYS THAT THE PLATE HAD BROKEN. A REVISION SURGERY HAS BEEN SCHEDULE BY THE SAME SURGEON THAT PERFORMED THE ORIGINAL PROCEDURE AND IT WILL TAKE PLACE AT THE SAME FACILITY. THIS REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2022 TO REMOVE ALL THE IMPLANTED SCREWS ALONG WITH THE BROKEN PLATE. ADDITIONAL INFORMATION RECEIVED ON 5/26/2022: DURING ORIGINAL PROCEDURE, SURGEON IMPLANTED THE FOLLOWING: ONE AR-2652CR CLAVICLE FRACTURE PLATE, ONE AR-2665-16H FRAGMENT SCREW, ONE AR-2665-18H FRAGMENT SCREW, ONE AR-2665-20H FRAGMENT SCREW, ONE AR-2665-22H FRAGMENT SCREW, ONE AR-8835-16 LOW PROFILE SCREW, ONE AR-8835-18 LOW PROFILE SCREW, TWO AR-8835-20 LOW PROFILE SCREWS, ONE AR-8835L-16 LOW PROFILE LOCKING SCREW, AND THREE AR-8835L-18 LOW PROFILE LOCKING SCREW. ALL THESE IMPLANTS WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY USING SYNTHES WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965957 LO-PRO SCRW TM,SS 3.5X 16MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT 14087773 00888867047297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other