BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOSTEAL ELEVATOR CURVED

    MDR report key: 10591239 · Received September 27, 2020

    Report

    Report Number
    1833053-2020-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 28, 2020
    Manufacturer
    INNOMED, INC.
    Product Code
    HTE
    UDI-DI
    00840277105547
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT MW5095964 WAS RECEIVED AT INNOMED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ON 8/28/2020 WITH FOLLOWING EVENT DESCRIPTION DOCUMENTED: "PATIENT HAVING SCHEDULED KNEE SURGERY. IN ONE OF THE EXTRA INSTRUMENT TRAYS THAT IS OCCASIONALLY USED. THERE WAS A SOFT TISSUE ELEVATOR NOTED TO BE BROKEN. INSTRUMENT WAS TAKEN OUT OF THE TRAY AND A NEW INSTRUMENT WAS OBTAINED. DID NOT REACH THE PATIENT. NO PATIENT HARM. FDA SAFETY REPORT ID #(B)(4). RESPONSE: IT IS CUSTOMARY FOR INNOMED TO RECEIVE THE AFFECTED DEVICE FOR EVALUATION AND INSPECTION. INNOMED WAS UNABLE TO CONTACT THE INITIAL REPORTER FOR REQUEST OF RETRIEVAL OF THE AFFECTED DEVICE AS THIS INFORMATION WAS NOT PROVIDED IN THE REPORT. INNOMED SURVEYED ITS INTERNAL COMPLAINTS DATABASE TO DETERMINE IF THERE WERE ANY ENTRIES OF THE PART WITH THE SAME DESCRIBED ISSUE. NO ENTRIES WERE FOUND. ADDITIONALLY, CURRENT INVENTORY OF THE PART WAS SURVEYED FOR THE DESCRIBED ISSUE. NONE WERE AFFECTED. THE DEVICE HAS BEEN ON THE MARKET SINCE FEBRUARY OF 2004, AND THIS IS THE FIRST ISSUE OF ITS KIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055849 PERIOSTEAL ELEVATOR CURVED ELEVATOR HTE INNOMED, INC. 3450 0817MT 00840277105547

    Patients

    Seq Age Sex Outcome Treatment
    1