BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW TM,SS 3.5X 18MMCORT

    MDR report key: 17908545 · Received October 10, 2023

    Report

    Report Number
    1220246-2023-08133
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    August 24, 2023
    Report Date
    February 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047303
    PMA / PMN Number
    K203239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PICTURES. VISUAL EVALUATION OF THE CUSTOMER-PROVIDED PICTURES NOTED THE SCREW HEAD HAD BROKEN OFF AND REMAINED ON THE DRIVER. REFER TO ATTACHMENTS. 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 USER ERROR OF THE DEVICE DUE TO OVER-TORQUEING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD AND/OR PRYING/LEVERAGING THE DRIVER WHILE ENGAGED WITH THE SCREW.

    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.

    Description of Event or Problem · 0

    ON 9/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8835-18 LOW PROFILE SCREW HAD AN ISSUE. DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO IMPLANT THE SCREW, THE HEAD OF THE SCREW BROKE OFF INSIDE THE PATIENT. THE HEAD OF THE SCREW WAS REMOVED, BUT THE REST OF THE SCREW REMAINED INSIDE THE CLAVICLE AS IT WAS SEATED FLUSH WITH THE PLATE. THE MAJORITY OF THE SCREWS WERE ALREADY SUCCESSFULLY IMPLANTED, SO THE LAST SCREW REMAINED INSIDE THE BONE AND WAS NOT REMOVED. THE SURGEON DEEMED IT SECURELY AFFIXED. THIS CAUSED A CASE DELAY OF OVER 15 MINUTES, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA HAD TO BE ADMINISTERED. THE SURGEON WAS CONCERNED THAT THE PATIENT MIGHT WANT THE HARDWARE REMOVED IN THE FUTURE AND THAT THERE MIGHT BE COMPLICATIONS AS THE SCREW WAS AFFIXED TO THE PLATE. THE CLAVICLE FRACTURE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS NO ADVERSE EFFECT OR HARM REPORTED. THE BROKEN SCREW FRAGMENT WAS DISCARDED, BUT A PICTURE WILL BE PROVIDED VIA EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302436 LO-PRO SCRW TM,SS 3.5X 18MMCORT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 18MMCORT 15014093 00888867047303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown