BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT W/DEPTH MARK QC/110MM

    MDR report key: 4244925 · Received November 12, 2014

    Report

    Report Number
    9612488-2014-10505
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    GFG
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. COMPLETE COMMON DEVICE NAME IS: BIT, MILLING, STERILE AND NON. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE COMPLAINED DRILL BIT SHOWS THAT THE SHAFT IS BROKE OFF DUE TO AN EXCESSIVE APPLIED MECHANICAL FORCE. THE DRILL BIT WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY (HARD BONE OR SHORT DURATION OF SLANT POSITION). 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE INSTRUMENT AND IS AN IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT IS BROKEN DURING SURGERY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730036 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT, MILLING, STERILE AND NON GFG SYNTHES BETTLACH 2796147

    Patients

    Seq Age Sex Outcome Treatment
    1