BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC TRAY

    MDR report key: 20230413 · Received September 16, 2024

    Report

    Report Number
    3007069947-2024-00002
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 27, 2024
    Report Date
    November 1, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    OJH
    UDI-DI
    00191072217431
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR COMPLAINT LOT WAS REVIEWED, THERE WERE NO ISSUES FOUND. CLEANING LOGS WERE REVIEWED, NO CONTRIBUTING ISSUES WERE DETECTED. LIKELY ROOT CAUSE WAS ASSEMBLY TEAMMATE FAILED TO PROPERLY PERFORM GOWNING SEQUENCE AND HAIR WAS MISSED DURING KIT VERIFICATION. A QUALITY ALERT WAS ISSUED STRESSING IMPORTANCE OF COMPLAINT INCIDENT. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    CUSTOMER FOUND FOREIGN MATERIAL IN PACKS WHICH CAUSED A 54 MIN DELAY IN PROCEDURE. DEBRIS WAS DISCOVERED PRIOR TO CASE START, REQUIRING NEW SET UP. NO OTHER PATIENT IMPACT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506499 ORTHOPEDIC TRAY ORTHOPEDIC TRAY OJH AMERICAN CONTRACT SYSTEMS, INC. 42-7845311 00191072217431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown