BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® 3.4MM(D) DRIVER TIP - SHORT

    MDR report key: 6597561 · Received May 30, 2017

    Report

    Report Number
    0001038806-2017-00272
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    April 27, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CERTAIN DRIVER TIP IMPDTS WAS RETURNED. UPON VISUAL INSPECTION, THE PRODUCT IDENTIFIED GENERAL SIGNS OF USAGE AROUND THE HEXES AND THE O-RINGS. THERE WAS NOTICEABLE WEAR AROUND THE SHAFT AND THE ISOLATCH BUT NO EVIDENCE OF ANY DAMAGE OR MALFUNCTION. IT ENGAGED AND DISENGAGED FROM A COMPATIBLE TEST IMPLANT AS INTENDED DURING FUNCTIONAL TESTING. COMPLAINT HISTORY REVIEW OF ETQ FOR LOT NUMBER 1193313 CONCLUDED THAT THERE ARE NO OTHER COMPLAINTS REPORTED AGAINST THE SUBJECT LOTS TO DATE. THE COMPLAINT WAS UNCONFIRMED. THE DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WHICH WOULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT THE DRIVER TIP DID NOT HOLD THE IMPLANT AND WHEN HE TRIED TO FORCE A LITTLE BIT TO HOLD TO THE IMPLANT IT GET STUCK. ANOTHER DRIVER TIPS WERE USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379205 CERTAIN® 3.4MM(D) DRIVER TIP - SHORT SHOR DRIVER TIP NDP BIOMET 3I 1193313

    Patients

    Seq Age Sex Outcome Treatment
    1