BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO SCRW TM SS 2.7X 14MMCORTEX

    MDR report key: 17326400 · Received July 14, 2023

    Report

    Report Number
    1220246-2023-07162
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    May 2, 2023
    Report Date
    November 2, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867046757
    PMA / PMN Number
    K141478
    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. ONE UNPACKAGED AR-8827-14 LOW PROFILE SCREW¿, 2.7 X 14 MM, CORTEX, BATCH 1074240, WAS RETURNED FOR INVESTIGATION. THE RETURNED SCREW WAS VISUALLY INSPECTED AND IT WAS NOTED THAT NO VISUAL ISSUES. UPON FUNCTIONAL TESTING WITH THE RETURNED MATING PART AR-2652CL, THE LOW-PROFILE SCREW FIT WAS TOO LOOSE ON THE LOCKING HOLES. THE SCREW IS TOO SMALL. 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.

    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
    654784 LO-PRO SCRW TM SS 2.7X 14MMCORTEX BONE FIXATION PLATE HRS ARTHREX, INC. LO-PRO SCRW TM SS 2.7X 14MMCORTEX 1074240 00888867046757

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other