BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG

    MDR report key: 11981718 · Received June 11, 2021

    Report

    Report Number
    0001038806-2021-00988
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 18, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G3: DATE RECEIVED BY MANUFACTURER H1: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE. ONE INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP ¿ LONG WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGHS OF WEAR BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED USING APPLICABLE IN-HOUSE IMPLANT. THE DEVICES WERE ABLE TO ENGAGE, RETAIN AND DISENGAGE AS NORMAL. PRE-EXISTING PATIENT CONDITIONS, TOOTH LOCATION AND X-RAY IMAGES ARE IRRELEVANT TO THIS INVESTIGATION. PER THE APPLICABLE IFU, IT IS STATED THAT SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS, INCLUDING PROLONGED USE, MISUSE, AND ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBERS WERE NOT PROVIDED. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IIPDTUL DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: FUNCTIONAL: DISENGAGED). AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DISENGAGEMENT OF IMPLANT DRIVERS. DOCTOR NOTICED THAT BOTH OF HER IIPDTUL AND IIPDTUS DRIVERS OF THE QNTSK40, LOT 121981 KIT WERE NOT GRIPPING THE IMPLANTS DURING A SURGICAL PROCEDURE. SHE CHANGED THE O-RINGS ON THESE DRIVERS BUT THIS DIDN'T MAKE ANY DIFFERENCE. THE DRIVERS HAVE ONLY BEEN USED FOR 25-30 IMPLANT PLACEMENTS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881543 INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG DENTAL DRIVER NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1