BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4145805 · Received October 6, 2014

    Report

    Report Number
    3000270450-2014-10116
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GFG
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE VISUAL INSPECTION OF THE RETURNED DEVICE BY THE COMPLAINT HANDLING UNIT REVEALED THE INSTRUMENTS ARE BROKEN AND THE REMAINING RETURNED SHAFTS WITH PARTIAL EDGES ARE BENT. EACH OF THE TWO DRILL BITS WERE RETURNED INCOMPLETE. THE SECOND PART FROM BOTH WITH EDGES AND DISTAL TIPS ARE MISSING AND THEREFORE COULD NOT BE EXAMINED. INVESTIGATION OF DOCUMENTATION FOR MANUFACTURING AND MATERIAL SHOWS THAT THE INSTRUMENTS PRODUCED IN 2012 PRINT SPECIFICATION. NO FAILURE IN MATERIAL OR MANUFACTURING COULD BE DETECTED THE COMPLAINT CONDITION IS LIKELY THE RESULT THAT THE INSTRUMENTS GOT STUCK EITHER IN THE BONE OR IN THE DRILL SLEEVE AND AS THE USER TURNED WITH HIGH FORCE, THE INSTRUMENTS GOT DAMAGED. WE RECOMMEND NOT TURNING THE DRILL BITS DURING INSERTION INTO THE DRILL SLEEVE IN ORDER TO PREVENT JAMMING IN IT. 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 THE DRILL BITS WERE BROKEN. THERE WASN¿T ANY IMPACT ON THE PROCEDURE, THE OPERATION WAS FINISHED SUCCESSFULLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622316 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT, SURGICAL GFG SYNTHES SELZACH 421160

    Patients

    Seq Age Sex Outcome Treatment
    1