BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE PUNCHER SIZE 3-4 - HINGE

    MDR report key: 9030694 · Received September 13, 2019

    Report

    Report Number
    3005180920-2019-00765
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040785631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 AUGUST 2019: LOT 1210553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE NO SIMILAR EVENTS REPORTED.

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY, THE SURGEON OBSERVED THAT THE SIZE 3-4 PUNCHER WAS MISSING THE ETCH MARKS USED TO MEASURE THE OFFSET. THE SURGEON WAS FINALLY ABLE TO MEASURE THE OFFSET WITHOUT THE ETCH MARKS BUT IT CAUSED A 50-MINUTE DELAY IN THE CASE. THE SURGEON WAS OBLIGED TO RELEASE THE TOURNIQUET AND TO WAIT TO PUT THE TOURNIQUET BACK UP TO CEMENT. THIS INSTRUMENT WAS FROM A CONSIGNMENT SET. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838172 GMK-HINGE PUNCHER SIZE 3-4 - HINGE SURGICAL INSTRUMENT FOR KNEE SURGERY LXH MEDACTA INTERNATIONAL SA 1210553 07630040785631

    Patients

    Seq Age Sex Outcome Treatment
    1 Other