BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM THREE-FLUTED DRILL BIT QC/110MM

    MDR report key: 9629521 · Received January 24, 2020

    Report

    Report Number
    8030965-2020-00655
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Report Date
    January 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819355460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS COMPANY REPRESENTATIVE. DEVICE HISTORY: PART: 315.250S. LOT: 3L36994. MANUFACTURING SITE: SELZACH. SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: 04. NOV. 2019. EXPIRY DATE: 01. OCT. 2029. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT 5L87407 IN BETTLACH AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 315.250 WITH LOT 5L87407 WERE REVIEWED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE UNSTERILE DEVICE LOT NUMBER 5L87407 , AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THREE (3) STERILE DRILL BITS HAD DIFFICULTLY DRILLING INTO BONE INTRAOPERATIVELY. ONE CASE THERE WERE 3 DRILL BITS OPENED AS THE FIRST TWO WEREN¿T DRILLING PROPERLY. A SECOND INSTANCE OCCURRED IN A CASE WHERE ONE (1) DRILL BIT WASN¿T WORKING PROPERLY. NO PATIENTS WERE ABLE TO BE IDENTIFIED. THE CASES WERE COMPLETED SUCCESSFULLY USING BACK-UP DRILL BITS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90255 2.5MM THREE-FLUTED DRILL BIT QC/110MM BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 6L36994 07611819355460

    Patients

    Seq Age Sex Outcome Treatment
    1