BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 19420703 · Received May 29, 2024

    Report

    Report Number
    1220246-2024-04308
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    August 11, 2020
    Report Date
    May 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K060478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE REPORTED EVENT IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY MRI/PHOTOS PROVIDED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT DUE TO THE PATIENT'S DEMINERALIZED BONE MATRIX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A KNEE SURGERY IN WHICH THREE ARTHREX BIO-COMPRESSION SCREWS WERE IMPLANTED, AND THE MRI IS SHOWING THAT ALL THREE SCREWS HAVE SNAPPED. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC ARTHROSCOPY RIGHT KNEE WITH DRILLING AND FIXATION OSTEOCHONDRITIS DISSECANS WITH BONE MARROW CONCENTRATE AND DEMINERALIZED BONE MATRIX. DURING THE PROCEDURE THREE ARTHREX BIO-COMPRESSION SCREWS WERE IMPLANTED. THEY WERE 3.7MM IN DIAMETER, TWO 20 MM AND ONE 18MM (SPECIFIC PART NUMBERS CURRENTLY UNKNOWN). THE OPERATIVE REPORT STATES THE LESION WAS STABLE AND WELL SEATED. A REVISION SURGERY HAS BEEN SCHEDULED TO REMOVE THE BROKEN SCREWS. THE REVISION IS TENTATIVELY SCHEDULED FOR (B)(6) 2021 TO TAKE PLACE AT THE SAME FACILITY AS THE PRIMARY. THE REVISION WILL BE PERFORMED BY A DIFFERENT SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275510 UNK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male