BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE

    MDR report key: 19916968 · Received August 6, 2024

    Report

    Report Number
    9610905-2024-00054
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HTW
    UDI-DI
    00888118041272
    PMA / PMN Number
    CLS 1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT PERCENTAGE WAS CALCULATED, AND IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WITHIN THE DESIGN RISK LIMITS ADHERED TO AT KLS SE. DURING THE INVESTIGATION THE PRODUCT LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, THE DEVICE HISTORY RECORDS WERE NOT REVIEWED. BASED ON THE INFORMATION PROVIDED THE RESULTS CONCLUDE THAT THE MOST LIKELY ROOT CAUSE IS USER RELATED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770260 LEVEL ONE TWIST DRILL HTW KLS MARTIN SE & CO. KG 25-469-11-07 UNKNOWN 00888118041272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other