BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOL HEX SST 1.25MM 22MM

    MDR report key: 6979750 · Received October 26, 2017

    Report

    Report Number
    0001038806-2017-00744
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NDP
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HEX TOOL WRENCH, LONG (HXL1.25) WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE HEXED TIP OF THE TOOL WRENCH HAD FRACTURED. THERE WERE NOTICEABLE SIGNS OF USAGE AROUND THE HANDLE AND THE SHANK. THEREFORE, THE COMPLAINT IS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR 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, DAMAGE, OR UNRECOGNIZABLE COLOR IDENTIFICATION, REPLACE THE INSTRUMENT(S) ACCORDINGLY. A SINGULAR ROOT CAUSE CANNOT BE DETERMINED. (B)(6). EVENT DATE UNKNOWN DUE TO FRACTURED DEVICE TIP BEING FOUND DURING INVESTIGATION. EXPIRATION DATE IS N/A (B)(4).

    Description of Event or Problem · 1

    DOCTOR INDICATED THAT THE HEX DRIVER TOOL (HXL1.25) DOES NOT HAVE A HEXAGON TIP AND CANNOT SCREW. THE RETURNED DEVICE WAS INVESTIGATED AND IT WAS THEN VERIFIED THAT THE TIP OF THE HEX DRIVER TOOL WAS FRACTURED, WHICH WAS NOT INITIALLY REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760553 TOOL HEX SST 1.25MM 22MM HEX TOOL NDP ZIMMER DENTAL 63614077

    Patients

    Seq Age Sex Outcome Treatment
    1