BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IASSIST V2 POD

    MDR report key: 19533138 · Received June 13, 2024

    Report

    Report Number
    0009617840-2024-00012
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    November 28, 2023
    Report Date
    June 13, 2024
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00887868519017
    PMA / PMN Number
    K213033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: SINGAPORE. VISUAL AND PHYSICAL EVALUATION OF THE RETURNED PRODUCT WAS COMPLETED AS PART OF THE COMPLAINT INVESTIGATION AND CONFIRMED THAT THE INNER PACKAGE WAS DEFORMED, LIKELY FROM HEAT. ADDITIONALLY, THE INNER PACKAGE WAS STILL SEALED, ONLY THE OUTER BOX WAS OPENED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO DEVIATIONS/ANOMALIES IDENTIFIED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE FOR THE REPORTED IS MOST LIKELY RELATED TO THE MANUFACTURING PROCESS. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, UPON UNSEALING THE I-ASSIST PODS BOX, THE INNER PLASTIC CONTAINER WAS OUT OF SHAPE. IT LOOKS LIKE IT HAS MELTED. THIS SET OF PODS WAS NOT USED. THE BOX WAS COMPLETELY SEALED AND KEPT IN A COOL ENVIRONMENT BEFORE IT WAS OPENED UP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937196 IASSIST V2 POD ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A MP0001298 00887868519017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown