BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS SCREW, Ø6.5MM X 85MM

    MDR report key: 18857594 · Received March 7, 2024

    Report

    Report Number
    1220246-2024-01348
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665022957
    PMA / PMN Number
    K123569
    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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE SHOWING A DAMAGED DEVICE.

    Description of Event or Problem · 0

    ON 2/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A 1310-040 ANTEGRADE FEMORAL NAIL HAD BEEN CRACKED INSIDE THE PATIENT AND WAS EXPERIENCING PAIN, WHICH WAS CONFIRMED BY AN X-RAY DONE ON THE PATIENT LAST WEEK. DURING THE ORIGINAL PROCEDURE OF AN ORIF LEFT FEMUR FRACTURE PROCEDURE ON 12/1/2023, A (1) 1310-040 ANTEGRADE FEMORAL NAIL/BATCH: 462737, (1) 8001-050 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN / (1) 8001-055 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN, (2) 8065-085 CANCELLOUS SCREW/BATCH: UNKNOWN AND BATCH: 472747, (1) 8065-090 CANCELLOUS SCREW/BATCH: 220505 ARTHREX PRODUCTS WERE IMPLANTED. THE ORIGINAL PROCEDURE HAD NO ISSUES REPORTED AND WAS COMPLETED SUCCESSFULLY. THE REMOVAL OF HARDWARE AND REPAIR OF THE LEFT FEMORAL ORIF FRACTURE REVISION PROCEDURE OCCURRED ON 2/20/2024. THE ARTHREX PRODUCTS THAT WERE EXPLANTED WERE (1) 1310-040 ANTEGRADE FEMORAL NAIL/BATCH: 462737, (1) 8001-050 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN / (1) 8001-055 CAPTURED CORTICAL SCREW/BATCH: UNKNOWN, (2) 8065-085 CANCELLOUS SCREW/BATCH: UNKNOWN AND BATCH: 472747, (1) 8065-090 CANCELLOUS SCREW/BATCH: 220505. ADDITIONAL INFORMATION FOR THE ARTHREX PRODUCTS IMPLANTED DURING THE REVISION HAS YET TO BE DISCOVERED SINCE THE SURGERY HAS YET TO BE COMPLETED. BOTH ORIGINAL SURGERY AND REVISION SURGERY TOOK PLACE AT THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880588 CANCELLOUS SCREW, Ø6.5MM X 85MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. CANCELLOUS SCREW, Ø6.5MM X 85MM UNK 00848665022957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other