BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30

    MDR report key: 7099368 · Received December 8, 2017

    Report

    Report Number
    0001038806-2017-00882
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ZIMMER DENTAL
    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

    (B)(6). AGE AND DATE OF BIRTH NOT PROVIDED. GENDER NOT PROVIDED. WEIGHT NOT PROVIDED. LOT NUMBER NOT PROVIDED/UNKNOWN.

    Additional Manufacturer Narrative · 1

    A LONG TORQUE WRENCH HEX DRIVER (TW1.25L) WAS RETURNED. VISUAL INSPECTION OF THE AS RECEIVED PRODUCT IDENTIFIED THAT THE HEX DRIVER TIP HAD FRACTURED. THE DRIVER TIP WAS DEFORMED (TWISTED). THERE WERE NOTICEABLE SIGNS OF WEAR DUE TO USAGE AROUND THE O-RING AND THE SHANK. 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: ZIMMER DENTAL: INSTRUCTIONS FOR USE FOR ZIMMER INSTRUMENT KIT SYSTEM AND DRIVER DRILLS (8874 REV 4-07/14). INFORMATION IDENTIFIED: 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. THE COMPLAINANT INDICATED THAT THE ¿INSTRUMENT FRACTURED BY THE TIP WHEN HE WAS SCREWING THE MHLAS SCREW AT 30 NCM¿. THE COMPLAINT WAS CONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION OF THE AS RECEIVED PRODUCTS. A ROOT CAUSE FOR THIS EVENT COULD NOT BE ASCERTAINED THERE ARE NO CORRECTIVE ACTIONS RECOMMENDED AT THIS TIME. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿. DEVICE MANUFACTURE DATE UNKNOWN; NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    DOCTOR INDICATED INSTRUMENT FRACTURED BY THE TIP PART, WHEN HE WAS SCREWING THE MHLAS SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878879 LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30 DRIVER NDP ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1