BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDLOC 2/0 PANACRYL (PLA/PDA) 12 DEGREE

    MDR report key: 1970505 · Received January 20, 2011

    Report

    Report Number
    1221934-2011-00028
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR, THE SURGEON EXPERIENCED A SEQUENCE OF EVENTS THAT ULTIMATELY CAUSED THE PROCEDURE TO BE ABANDONED AND THE PT MOVED TO ANOTHER FACILITY FOR REPAIR. THE SURGEON WAS USING MITEK RAPIDLOK MENISCAL FIXATIONS DEVICES AND A MITEK MENISCAL APPLIER TO FACILITATE A MENISCAL REPAIR. IT APPEARS THAT THE 1ST MENISCAL APPLIER DID NOT WORK; A 2ND APPLIER WAS EMPLOYED TO DEPLOY THE FIXATION DEVICES; THE 1ST DEVICE DEPLOYED AND FIXATED PROPERLY, HOWEVER, ON THE NEXT 3 DEVICES, THE SUTURES BROKE RENDERING THE DEVICES USELESS. FOR WHATEVER REASON, THIS WAS ALL OF THE MENISCAL FIXATION DEVICES THAT THE FACILITY HAD IN THEIR POSSESSION; IT IS AT THIS POINT THAT THE SURGEON CHOSE THE ABANDONED PROCEDURE; THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR REMEDY. THIS IS ALL OF THE INFO MADE AVAILABLE AT THIS TIME; THERE ARE QUESTIONS OUT FOR FURTHER DETAIL AND CLARITY. ALSO SEE ASSOCIATED MDRS 1221934-2011-00027, 1221934-2011-00029 AND 1221934-2011-00030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLOC 2/0 PANACRYL (PLA/PDA) 12 DEGREE MENISCAL FASTENER MBI DEPUY MITEK 228311 3433229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention