BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB LS STRAIGHT PIN KIT

    MDR report key: 7387072 · Received March 30, 2018

    Report

    Report Number
    0001825034-2018-02274
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. ORTHOSORB KIT COMPONENTS WERE RETURNED FOR EVALUATION WITHOUT THE PACKAGING (TRAY) OF THE KIT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. WITHOUT THE OPPORTUNITY TO EXAMINE THE PACKAGING OF THE COMPLAINT PRODUCT, THE COMPLAINT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ORTHOSORB MISSING FROM THE STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227657 ORTHOSORB LS STRAIGHT PIN KIT KNEE INSTRUMENT OVZ ZIMMER BIOMET, INC. N/A 848720

    Patients

    Seq Age Sex Outcome Treatment
    1