BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANALOK LOOP RC ANCHOR

    MDR report key: 1001864 · Received February 25, 2008

    Report

    Report Number
    1221934-2008-00094
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    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

    NOTHING IS BEING RETURNED FOR A FAILURE ANALYSIS, HOWEVER, THIS TYPE OF FAILURE HAS HISTORICALLY BEEN ATTRIBUTED TO USER TECHNIQUE. FROM AN ENGINEERING PERSPECTIVE, DAMAGE TO THE INSERTER, "TIP BREAKAGE", MAY HAVE BEEN CAUSED BY OFF-ANGLE OR OFF AXIS INSERTION INTO THE BONE HOLE. OFF ANGLE/AXIS INSERTION IS THE MOST LIKELY CAUSE FOR THE INSERTER DISTAL TIP FAILURE, USUALLY THE RESULT OF BENDING AND/OR TWISTING THE ANCHOR DURING DEPLOYMENT DUE TO ANCHOR/BONE HOLE MISALIGNMENT. THE IFU STATES NOT TO TWIST AND/OR BEND THE INSERTER UPON INSERTION AS THE ANCHOR, SUTURE AND/OR INSERTER TIP MAY BE DAMAGED. NO FURTHER ACTION IS WARRANTED, HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTS THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF A PANALOK INSERTER BROKE OFF INTO ITS RESPECTIVE ANCHOR AND REMAINS WITHIN THE ANCHOR WHICH REMAINS SEATED IN THE BONE HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANALOK LOOP RC ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210702 3077426

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK