BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO LOCK SCRW,SS 3.5X 14MM

    MDR report key: 17465826 · Received August 4, 2023

    Report

    Report Number
    1220246-2023-07439
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    May 2, 2023
    Report Date
    October 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047549
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. ONE UNPACKAGED AR-8835L-14 LO-PRO LOCK SCRW, SS 3.5X 14MM, BATCH 15040867, WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND NO DEFECTS WERE FOUND. UPON FUNCTIONAL TESTING WITH THE RETURNED MATING PART AR-2652CL, THE LOW-PROFILE LOCKING SCREW SITS FLUSH IN ALL LOCKING PLATES' HOLES. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS A USER ERROR. PER DFU-0125 AT REV. 2. G. 1. SURGEONS MUST APPLY THEIR PROFESSIONAL JUDGMENT WHEN DETERMINING THE APPROPRIATE SCREW SIZE BASED ON THE SPECIFIC INDICATION, PREFERRED SURGICAL TECHNIQUE, AND PATIENT HISTORY. 2. SURGEONS ARE ADVISED TO REVIEW THE PRODUCT-SPECIFIC SURGICAL TECHNIQUE PRIOR TO PERFORMING ANY SURGERY. ARTHREX PROVIDES DETAILED SURGICAL TECHNIQUES IN PRINT, VIDEO, AND ELECTRONIC FORMATS. THE ARTHREX WEBSITE ALSO PROVIDES DETAILED SURGICAL TECHNIQUE INFORMATION AND DEMONSTRATIONS. OR CONTACT YOUR ARTHREX REPRESENTATIVE FOR AN ONSITE DEMONSTRATION. 3. USE THE APPROPRIATELY SIZED DRILL BIT FOR THE SCREW. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW HAS LOOSENED IN THE CLAVICLE PLATE. NO FURTHER INFORMATION RECEIVED. 27-JUN-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES BECAME LOOSE POST OP. AR-2652CL BATCH: 5262102 AR-8835L-14 BATCH: 15040867 AR-8835-14 BATCH: 10694746 2X AR-8835-16 BATCH: 1072011 3X AR-8835-18 BATCH: 10591283 AR-8827-14 BATCH: 1074240 AS THE REPORTED DEVICES ARE AVAILABLE FOR RETURN A REVISION SURGERY HAD TO BE PERFORMED BUT NO FURTHER INFORMATION WERE PROVIDED WHEN THE REVISION SURGERY WAS PERFORMED. 13-JUL-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT A REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660081 LO-PRO LOCK SCRW,SS 3.5X 14MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 14MM 15040867 00888867047549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown