BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOL HEX SST 1.25MM 22MM

    MDR report key: 7286242 · Received February 21, 2018

    Report

    Report Number
    0001038806-2018-00139
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    November 17, 2017
    Report Date
    March 28, 2018
    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 · 0

    ONE HEX DRIVER WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE TIP WAS FRACTURED. NO ADDITIONAL DAMAGES WERE NOTED ON THE HEX DRIVER. THE ALLEGED COMPLAINT WAS 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 AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: ZIMMER DENTAL INSTRUCTION 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. CLEANING/STERILIZATION INFORMATION DISINFECTION AND STERILIZATION PROCEDURES SHOULD CONFORM TO OSHA OR LOCAL GUIDELINES FOR BLOOD BORNE PATHOGENS. CLINICALLY CONTAMINATED IMPLANTS SHOULD NOT BE CLEANED AND RESTERILIZED UNDER ANY CIRCUMSTANCES. IMPROPER CLEANING COULD LEAD TO INADEQUATE STERILIZATION. CLEANING USE THE FOLLOWING GUIDELINES FOR CLEANING PRODUCTS: DRILLS, INSTRUMENTS AND COMPONENTS - DISASSEMBLE MULTI-PIECE COMPONENTS, IF APPLICABLE. RINSE WITH COOL-TO-LUKEWARM DRINKABLE, TAP WATER FOR TWO-AND-ONE-HALF MINUTES. FOR DRILLS, USE THE ZIMMER CLEANING WIRE TO REMOVE ANY DEBRIS FROM THE IRRIGATION CHANNEL. USING A 25 GAUGE NEEDLE, FLUSH THE DRILL LUMEN WITH WATER TO REMOVE ANY REMAINING DEBRIS. FOR ALL PARTS PLACE IN AN ULTRASONIC CLEANER WITH AN ENZYMATIC DETERGENT DILUTED WITH TAP WATER PER THE MANUFACTURE¿S GUIDELINES. SONICATE FOR 10 MINUTES. RINSE WITH DRINKABLE, TAP WATER FOR THREE MINUTES. KITS, TRAYS, AND BLOCKS - REMOVE ALL PARTS AND INSERT FROM THE TRAY. CLEAN PARTS PER THE ABOVE INSTRUCTIONS. THOROUGHLY RINSE THE KITS UNDER DRINKABLE, TAP WATER TO REMOVE ALL VISIBLE SOIL. USE A SOFT BRISTLE BRUSH TO CLEAN THE KITS UNTIL ALL VISIBLE SOIL IS REMOVED. A SYRINGE OR PIPE CLEANER MAY BE USED TO AID IN THE RINSING. ASSURE THAT ALL HARD TO REACH AREAS ARE ACCESSED. AFTER THE RINSING, PREPARE THE ENZYMATIC DETERGENT FOLLOWING THE MANUFACTURER¿S SPECIFICATIONS. FULLY IMMERSE THE KIT IN THE PREPARED DETERGENT AND ALLOW THE KIT TO SOAK IN THE DETERGENT FOR A MINIMUM OF ONE MINUTE. FOLLOWING THE SOAK USE A DAMP CLOTH AND/OR A SOFT BRISTLE BRUSH TO WIPE AND REMOVE ANY EXCESS DEBRIS/SOIL FROM EACH COMPONENT. A SYRINGE OR A PIPE CLEANER MAY BE USED TO AID IN THE CLEANING. RINSE THE KITS WITH LUKEWARM TAP WATER TO ELIMINATE ALL RESIDUAL ENZYMES AND DETERGENT, THOROUGHLY FOR A MINIMUM OF THREE MINUTES. DRY THE COMPONENTS. REASSEMBLE THE CONTENTS OF THE KIT AND FOLLOW THE GUIDELINES FOR STERILIZATION. NOTE: THIS PROCEDURE SHOULD BE PERFORMED AFTER AN INSTRUMENT USED DURING A SURGERY COMES INTO CONTACT WITH THE SURGICAL TRAY. STERILIZATION WHEN STERILIZING INDIVIDUAL PARTS, PARTS SHOULD BE PLACED IN STERILIZATION POUCH PRIOR TO STERILIZATION. WHEN STERILIZING PARTS WITHIN A KIT, PARTS SHOULD BE PLACED IN APPROPRIATE LOCATIONS IN THE KIT AND THE POPULATED KIT SHOULD BE PLACED IN STERILIZATION POUCH AND SEALED. THE FOLLOWING VALIDATED STERILIZATION PARAMETERS (METHOD, TIME AND TEMPERATURE) ARE REQUIRED TO ACHIEVE A 10-6 STERILITY ASSURANCE LEVEL (SAL). LOCAL OR NATIONAL SPECIFICATIONS SHOULD BE FOLLOWED WHERE STEAM STERILIZATION REQUIREMENTS ARE STRICTER OR MORE CONSERVATIVE THAN THOSE LISTED IN THE TABLE. EXCEEDING THESE STERILIZATION PARAMETERS MAY RESULT IN DAMAGE TO PLASTIC COMPONENTS. VERIFY THE CALIBRATION OF YOUR UNIT TO ENSURE RECOMMENDED TEMPERATURES ARE REACHED. TO ENSURE AUTOCLAVE IS PERFORMING EFFECTIVELY, PERIODIC USE OF BIOLOGIC INDICATORS SHOULD BE CONSIDERED. CHEMICLAVE STERILIZATION IS NOT RECOMMENDED FOR ANY ZIMMER DENTAL PRODUCTS. STORE IN THE STERILIZATION POUCH UNTIL USE. A SINGULAR CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: DEVICE EXPIRATION IS N/A. D4: (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE AND DATE OF BIRTH NOT PROVIDED/UNKNOWN. PATIENT'S GENDER NOT PROVIDED/UNKNOWN. PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEX DRIVER (HXL1.35) FRACTURED DURING IMPLANT PLACEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRIVER. TOOTH LOCATION 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130618 TOOL HEX SST 1.25MM 22MM HEX DRIVER NDP ZIMMER DENTAL 63803858

    Patients

    Seq Age Sex Outcome Treatment
    1