BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP

    MDR report key: 10896369 · Received November 24, 2020

    Report

    Report Number
    0001032347-2020-00589
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 10, 2020
    Report Date
    June 9, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013189
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THAT THE DRILL HAD FRACTURED AT THE START OF THE FLUTED SECTION. THE DRILL'S IDENTITY WAS CONFIRMED TO BE ITEM# 01-7146, VENDOR LOT# 155565. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE RAW MATERIAL CERTIFICATE SHOWED MATERIAL IS CONFORMING TO SPECIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. D4 - THE LOT NUMBER (155565) ETCHED ON THE DRILL IS THE VENDOR'S LOT NUMBER. BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE TWO (2) POSSIBLE ZIMMER BIOMET LOTS: 250370 (MFG DATE: SEP 2012), 099510 (MFG DATE: AUG 2012).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL FRACTURED DURING AN OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE. THE SURGEON DRILLED A PILOT HOLE WHILE FIXING A PLATE TO THE ZYGOMATIC FRONTAL SUTURE AND FOUND THE DRILL WAS DAMAGED AFTER USE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361285 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036013189

    Patients

    Seq Age Sex Outcome Treatment
    1