BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.25 HEX TL,GEMLOCK RETEN

    MDR report key: 16511416 · Received March 9, 2023

    Report

    Report Number
    0001038806-2023-00464
    Event Type
    Injury
    Date Received
    March 9, 2023
    Report Date
    March 9, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED; AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED; PATIENT SEX UNKNOWN / NOT PROVIDED; WEIGHT UNKNOWN / NOT PROVIDED; DATE OF EVENT UNKNOWN / NOT PROVIDED; BRAND NAME UNKNOWN / NOT PROVIDED; LOT NUMBER UNKNOWN / NOT PROVIDED; UDI NOT AVAILABLE; INITIAL REPORTER EMAIL ADDRESS UNKNOWN / NOT PROVIDED; PMA/510(K) NUMBER; DEVICE MANUFACTURE DATE NOT AVAILABLE, LOT NUMBER UNKNOWN. VISUAL EVALUATION OF THE RETURNED PRODUCTS IDENTIFIED THE HXGR1.25 DRIVER IS FRACTURED AT THE TIP AND THAT ONE OF THE MOUNTS (FMT4) HAD A FRACTURED HEX CONNECTION, WHILE THE OTHER HAD NO MALFUNCTION. THE TSVMWB10 WAS NOT RETURNED AS IT REMAINS IMPLANTED, SO VISUAL EVALUATION COULD NOT BE COMPLETED, AND MALFUNCTION COULD NOT BE VERIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES & EVENT. PREEXISTING CONDITION NOTED WAS UNKNOWN BONE DENSITY. THE REPORTED DEVICES WERE AT AN UNKNOWN TOOTH LOCATION. ADDITIONALLY, IT IS NOT KNOWN HOW LONG THE MOUNTS AND THE DRIVER WERE IN USE. THE CUSTOMER DID NOT PROVIDE X-RAYS OR IMAGES. DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS (IFU4869 REV 9 10/2019). ZIMMER® INSTRUMENT KIT SYSTEM, DENTAL SINGLE PATIENT DRILLS, DRIVA¿ DRILLS, AND TOOLS (IFU8874 REV 5 08/2019). INFORMATION IDENTIFIED: 'WARNINGS' 'PRECAUTIONS' 'STERILITY' 'POTENTIAL ADVERSE EVENTS'. DHR AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED DATING BACK TO 12 MONTHS PRIOR TO THE NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICES RELATED TO THE REPORTED EVENT. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR FOR THE HXGR1.25, AND THE REPORTED EVENT OF FRACTURE WAS CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED ABUTMENT (MULTIPLE USES MOUNT) FRACTURED INSIDE OF THE IMPLANT (80 NEW TORQUE) AND DRIVER FRACTURED INSIDE OF ABUTMENT. PROCEDURE HAS NOT BEEN COMPLETED WITH OTHER DEVICES. UPON INVESTIGATION IT HAS BEEN DISCOVERED THAT THE DRIVER WAS FRACTURED AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863631 1.25 HEX TL,GEMLOCK RETEN DENTAL DRIVER NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention