BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG

    MDR report key: 2498905 · Received March 21, 2012

    Report

    Report Number
    0002242816-2012-00025
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 23, 2012
    Manufacturer
    EBI, LLC
    Product Code
    MNH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED PLUG CONFIRMED THE REPORTED EVENT. THE PENTALOBE TULIP WAS FOUND TO BE SEVERELY DAMAGED HOWEVER THERE IS NO EVIDENCE THAT THE PLUG WAS CROSS-THREADED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES WERE FOUND IN THE DOCUMENTATION. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED EVENT IS EXCESSIVE TORQUE FORCES APPLIED BY AN INSERTER THAT MAY HAVE NOT BEEN FULLY ENGAGED WITH THE PLUG. UNDER THOSE CONDITIONS, THE INSERTER APPLIES ALL THE LOAD ON THE SUPERIOR PORTION OF THE PENTALOBE TULIP. APPLYING EXCESSIVE FORCE WHILE PARTIALLY CONNECTED TO THE PLUG INCREASES THE RISK OF DAMAGE TO THE INSTRUMENT AND PLUG. NO ADVERSE EFFECT WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADING OF A PLUG SHEARED DURING USE. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUG PLUG MNH EBI, LLC N/A J2464365

    Patients

    Seq Age Sex Outcome Treatment
    1