BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE

    MDR report key: 19825786 · Received July 25, 2024

    Report

    Report Number
    9610905-2024-00042
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 8, 2024
    Report Date
    January 16, 2025
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HTW
    UDI-DI
    00888118040817
    PMA / PMN Number
    CLS 1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED NO MANUFACTURING ISSUES, NO DESIGN ISSUES AND/OR CORRECTIVE ACTIONS NECESSARY AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU. LOTS IDENTIFIED: 33606099 - MFG DATE 04/03/2024; 33606103 - MFG DATE 04/08/2024.

    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
    351082 LEVEL ONE TWIST DRILL HTW KLS MARTIN SE & CO. KG 25-449-16-91 SEE H11 00888118040817

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other