BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALLUX OSTEOTOMY PLATE, 8MM

    MDR report key: 8230298 · Received January 9, 2019

    Report

    Report Number
    3004369035-2016-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Report Date
    January 9, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120047298664
    PMA / PMN Number
    K131722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF HALLUX PLATES WERE INSPECTED AND SHOWED DEVIATIONS IN DISTAL MEASUREMENT. THE FIELD OF TOLERANCE OF THE NOMINAL SIZE IS 8.00MM AND 7.90. THE ACTUAL SIZE OF THE AFFECTED LOTS WAS BETWEEN 8.11 AND 8,16. ALL OTHER MEASUREMENTS INCLUDING THE HOLE CLEARANCE ARE WITHIN THE FIELD OF TOLERANCE. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO DEVIATION. THE MATERIAL WAS DETERMINED TO BE CONFORMING AND WAS USED AS IS PER PRODUCT DEVELOPMENT APPROVAL. AS A RESULT, THE AFFECTED PLATES GOT EXCHANGED AND THE INCIDENT WAS FILED IN ADDITION UNDER THE CAPA NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HALLUX OSTEOTOMY PLATE COULDN'T BE MOUNTED ON THE INSERTION GUIDE. THE INCIDENT DIDN'T HAPPEN DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23608 HALLUX OSTEOTOMY PLATE, 8MM HALLUX OSTEOTOMY PLATE, 8MM HRS I.T.S. GMBH 21015-08 09120047298664

    Patients

    Seq Age Sex Outcome Treatment
    1