BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 6024511 · Received October 12, 2016

    Report

    Report Number
    3000327445-2016-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 5, 2016
    Report Date
    October 4, 2016
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION WILL BE UNDERTAKEN SINCE THIS WAS THE FIRST TIME OCCURRENCE OF THIS TYPE OF FAILURE. THE ORIGIN OF THE FAILURE IS UNCERTAIN. FOLLOWING THE INVESTIGATION, IT APPEARS THE DISASSEMBLY OF THIS PARTICULAR ASSEMBLY WAS MAYBE TIGHTER THAN OTHER ASSEMBLIES OF THE SAME SYSTEM; HOWEVER, THIS SITUATION WOULD NOT JUSTIFY THE FAILURE OF THE PART BY ITS OWN. IT IS SUSPECTED THAT THE DISASSEMBLY OF THE INSTRUMENT WAS NOT PROPERLY DONE AND HIGHER FORCES THAN NECESSARY WERE APPLIED ON THE PART.

    Description of Event or Problem · 1

    THE TARGETING DEVICE BROKE AT THE LEVEL OF THE CONNECTION WITH THE LAG SCREW ATTACHMENT DURING THE INSERTION OF THE MECHANICAL SCREW WHILST USING THE LAG SCREW ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674467 GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC. 110929-001

    Patients

    Seq Age Sex Outcome Treatment
    1