BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANALOK LOOP ANCHOR

    MDR report key: 746231 · Received July 27, 2006

    Report

    Report Number
    1221934-2006-00155
    Event Type
    Malfunction
    Date Received
    July 27, 2006
    Date of Event
    July 24, 2006
    Report Date
    July 24, 2006
    Manufacturer
    DEPUY MITEK
    Product Code
    KGS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN WHICH OF THE 3 DEVICE LOTS USED IN THE PROCEDURE IS THE ACTUAL DEVICE RELATIVE TO THE REPORTED INCIDENT, SO A BATCH REVIEW FOR ALL 3 LOTS WAS CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THESE 3 BATCHES OF PRODUCT WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THESE 3 LOTS; LOT 0601154, LOT 0602170 AND LOT 062265 THAT WERE RELEASED TO DISTRIBUTION. ALTHOUGH THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED FOR A FAILURE ANALYSIS, 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 OF-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. WHEN THE DEVICE IS RECEIVED, IT WILL BE FORWARDED TO THE DEPUY MITEK QAE AND R&D GROUPS FOR A FAILURE ANALYSIS. IF THE RESULTS OF SAID INVESTIGATION DIFFER FROM THE ABOVE HYPOTHESIS A FOLLOW UP REPORT REFLECTING THE FAILURE ANALYSIS CONCLUSIONS WILL BE FILED.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING A SHOULDER PROCEDURE ON OF THE 3 FIXATION DEVICES HAD THE TIP OF THE INSERTER MECHANISM BREAK OFF INTO THE ANCHOR AND REMAINS THEREIN THE ANCHOR WITHIN THE BODY. THE CASE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANALOK LOOP ANCHOR SHOFT TISSUE FIXATION DEVICE KGS DEPUY MITEK 210704 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN