BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POPLOK PUNCH 3.5MM

    MDR report key: 2683549 · Received August 6, 2012

    Report

    Report Number
    1017294-2012-00039
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Report Date
    July 11, 2012
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC RECEIVED THIS POPLOK PUNCH FOR EVALUATION AND CONFIRMED THE REPORTED NONCONFORMANCE. VISUAL EXAMINATION OF THE RETURNED INSTRUMENT FOUND THE HANDLE IS FOR A 3.5MM POPLOK ANCHOR, BUT THAT THE SHAFT IS ETCHED AS PKL-45M, AND MEASURED 4.5MM IN DIAMETER. A TWO YEAR REVIEW OF COMPLAINT HISTORY SHOWED NO OTHER COMPLAINTS FOR THIS LOT OF PRODUCT, AND NO SERIOUS INJURIES OR DEATHS DUE TO THIS NONCONFORMANCE. THE NONCONFORMANCE IS ADDRESSED IN THE RISK DOCUMENT. A CAPA IS CURRENTLY IN PROCESS TO PREVENT FUTURE RECURRENCE. THIS LOT WAS PRODUCED PRIOR TO THE RECOMMENDED CORRECTIVE ACTIONS, WITH 10 ITEMS PRODUCED IN THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CONMED LINVATEC (B)(6) THAT DURING AN INCOMING INSPECTION OF PRODUCT, "IT WAS DISCOVERED BY A LINVATEC EMPLOYEE THAT THE PRODUCT HANDLE AND PACKAGING IS LABELED AS PKL-35M, BUT THE SHAFT IS ETCHED AS PKL-45M". THIS ITEM WAS NEVER SENT TO AN END USER, AND THEREFORE; NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POPLOK PUNCH 3.5MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 256058

    Patients

    Seq Age Sex Outcome Treatment
    1