BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM,SS 3.5X 18MMCORT

    MDR report key: 17326453 · Received July 14, 2023

    Report

    Report Number
    1220246-2023-07165
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    May 2, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047303
    PMA / PMN Number
    K203239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. TWO UNPACKAGED AR-8835-18 LOW PROFILE SCREW¿, SS, 3.5 X 18 MM, CORTICAL, BATCH 10591283, WERE RETURNED FOR INVESTIGATION. THE RETURNED SCREWS WERE VISUALLY INSPECTED, AND IT WAS NOTED THAT THERE WERE NO VISUAL DEFECTS. UPON FUNCTIONAL TESTING WITH THE RETURNED MATING PART AR-2652CL, THE LOW-PROFILE SCREWS FIT TOO LOOSE ON THE LOCKING HOLES. HOWEVER, THE SCREWS ARE THE CORRECT SIZE PER DRAWING C18816 AT REVISION 1. 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.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806293 LO-PRO SCRW TM,SS 3.5X 18MMCORT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 18MMCORT 10591283 00888867047303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other