BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANALOK LOOP ANCHOR

    MDR report key: 1800122 · Received August 10, 2010

    Report

    Report Number
    1221934-2010-00279
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTS TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SUTURES OF 2 PANALOK FIXATION DEVICES BROKE AWAY WHEN THE SURGEON WAS SNUGGING THEM UP; THE ANCHORS THEMSELVES REMAIN CONTAINED IN THE BONE. THE SURGEON USED OTHER FIXATION DEVICES TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. HOWEVER, BECAUSE OF THE SUTURE ISSUE, THE PROCEDURE WAS EXTENDED BY AN HOUR. NOTHING IS BEING RETURNED. ALSO SEE ASSOCIATED MDR 1221934-2010-00280.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANALOK LOOP ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210704 3415555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK