BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1.25MM HEX SST

    MDR report key: 6701782 · Received July 11, 2017

    Report

    Report Number
    0001038806-2017-00404
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 12, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT # WAS NOT PROVIDED/UNKNOWN

    Additional Manufacturer Narrative · 1

    ONE TRABECULAR METAL IMPLANT WAS RETURNED WITH AN IMPRESSION COPING ENGAGED TO THE DRIVE FEATURE. VISUAL INSPECTION OF THE AS RECEIVED PRODUCTS IDENTIFIED A FRACTURED HEX DRILL TIP (HX1.25D) STUCK IN THE IMPRESSION COPING. NO ADDITIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RETURNED PRODUCTS. THE COMPLAINT IS CONFIRMED. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTION OF USE FOR ZIMMER INSTRUMENT KIT SYSTEM AND DRIVA DRILLS (8874 REV 4-07/14) WARNINGS SURGICAL AND RESTORATIVE TECHNIQUES REQUIRED TO PLACE DENTAL IMPLANTS ARE HIGHLY SPECIALIZED AND COMPLEX PROCEDURES. PRACTITIONERS SHOULD ATTEND COURSES OF STUDY TO FAMILIARIZE THEMSELVES WITH IMPLANTOLOGY TECHNIQUES. IMPROPER TECHNIQUE CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. ZIMMER DENTAL IMPLANT SYSTEMS ARE INTENDED TO BE USED ONLY WITH ZIMMER DENTAL SPECIALLY DESIGNED BONE DRILLS AND PROSTHETICS. IMPLANTS PLACED AT UNSUITABLE ANGLES RELATIVE TO EXISTING DENTITION OR MULTIPLE IMPLANTS PLACED AT CONVERGENT/DIVERGENT MANNER CAN RESULT IN COMPLEX RESTORATIONS THAT MAY OVERLOAD IMPLANTS, POTENTIALLY LEADING TO IMPLANT FAILURE (INCLUDING FRACTURE). A THOROUGH DIAGNOSTIC WORK-UP AND USE OF X-RAYS AND SURGICAL TEMPLATES ARE RECOMMENDED TO HELP ENSURE PROPER ANGULATION AND AVOIDANCE OF CERTAIN ANATOMICAL FEATURES SUCH AS SINUS MEMBRANES, ADJACENT TEETH AND CRANIOFACIAL NERVES. PRECAUTIONS ASSEMBLED KITS MUST BE STORED AND STERILIZED HORIZONTALLY WITH COVER IN PLACE AND ZIMMER LOGO FACING UP. SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE AND WEAR AND SHOULD BE INSPECTED AND CLEANED BEFORE EACH USE. THE NUMBER OF USES PER DRILL WILL VARY AND DEPENDS ON A VARIETY OF FACTORS INCLUDING BONE DENSITY ENCOUNTERED, PROPER HANDLING AND CLEANING. OVER TIME, REPEAT STERILIZATION MAY AFFECT CUTTING EFFICIENCY AND COLOR APPEARANCE. CUTTING EDGES SHOULD PRESENT A CONTINUOUS EDGE AND APPEAR SHARP. CHECK THE LATCH LOCK SHANK FOR WEAR TO ENSURE THE CONNECTION IS NOT DAMAGED. IF INSPECTION REVEALS SIGNS OF WEAR, A SINGULAR CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT WHEN TRYING TO REMOVE AN IMPRESSION COPING, THE DRILL BROKE OFF INSIDE OF THE IMPLANT. THEY HAD TO REMOVE THE IMPLANT. THEY WERE ABLE TO COMPLETE THE PROCEDURE AND WERE ABLE TO PLACE ANOTHER IMPLANT. THE DRILL TIP IS STUCK BETWEEN THE TRANSFER MOUNT/IMPLANT. THE OTHER PORTION WAS DISCARDED. TOOTH LOCATION #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482043 DRILL 1.25MM HEX SST HEX DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1