BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POPLOK PUNCH, 3.5MM

    MDR report key: 2631923 · Received June 28, 2012

    Report

    Report Number
    1017294-2012-00032
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    May 29, 2012
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC RECEIVED THIS POPLOK PUNCH FOR EVALUATION AND CONFIRMED THE REPORTED MISASSEMBLED. VISUAL EXAMINATION OF THE RETURNED INSTRUMENT FOUND IT HAD 3.5MM POPLOK ANCHOR ETCHED ON THE BLUE HANDLE, BUT THAT THE SHAFT WAS ETCHED AS PKL-45M. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE ROOT CAUSE OF THIS REPORTED PROBLEM AND A FOLLOW-UP WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PKL-35M POPLOK PUNCH 3.5MM WAS INCORRECTLY ASSEMBLED IN THAT THE HANDLE IS FOR A 3.5MM POPLOK PUNCH, BUT THE DRIVER SHAFT IS FOR A 4.5MM POPLOK PUNCH. THIS DISCREPANCY WAS EASILY IDENTIFIED BY THE USER/SURGICAL STAFF BEFORE USE. THERE HAVE BEEN NO PATIENT INVOLVEMENT AND/OR INJURIES ASSOCIATED WITH THIS NON-CONFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POPLOK PUNCH, 3.5MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 318455

    Patients

    Seq Age Sex Outcome Treatment
    1