BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP

    MDR report key: 10917837 · Received November 30, 2020

    Report

    Report Number
    0001032347-2020-00592
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    November 12, 2020
    Report Date
    June 25, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013165
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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. THE TW DRILL 1.1X50MM 7MMSTOP W/NT (ITEM# 01-7144, LOT# 210575) WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE 210575 ETCHED ON THE BODY OF THESE DRILLS IS THE VENDOR'S LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE 3 POSSIBLE ZIMMER BIOMET LOTS: 210510, 210520, OR 930610. VISUAL EXAMINATION OF THE RETURNED DRILL CONFIRMED THE PRODUCT'S IDENTITY. IT WAS ALSO CONFIRMED THAT THE DRILL WAS FRACTURED, NEAR THE NECK AT THE START OF THE FLUTED SECTION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE SUPPLIER DHR WAS NOT REQUESTED BECAUSE THE RAW MATERIAL CERTIFICATE SHOWED MATERIAL IS CONFORMING TO SPECIFICATION, INCLUDING THE MATERIAL HARDNESS. 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. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION D4, D9, H2, H3, H6 AND H10. D4 ¿ THERE ARE THREE (3) POSSIBLE LOT NUMBERS LOT# 210510, UDI# (B)(4), MANUFACTURE DATE: 16 FEB 2015 LOT# 210520, UDI# (B)(4) , MANUFACTURE DATE: 17 FEB 2015 LOT# 930610, UDI# ((B)(4) , MANUFACTURE DATE: 20 JAN 2020.

    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. SERIAL NUMBER: CUSTOMER PROVIDED THE VENDOR LOT NUMBER / SERIAL NUMBER (B)(4). HOWEVER, THIS NUMBER APPEARS TO BE INVALID AS THERE IS NO RECORD OF THIS VENDOR LOT NUMBER. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DRILL BIT FRACTURED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A ZYGOMATIC FRACTURE RESULTING IN A ONE (1) HOUR DELAY. THE DRILL TIP BROKE WHEN THE SURGEON FIXED THE INFRAORBITAL MARGIN. THE SURGERY WAS DELAYED FOR ABOUT AN HOUR TO FIND AND REMOVE THE BROKEN DRILL TIP. THE SURGEON SCRAPED THE SURROUNDING BONE, TOOK AN X-RAY, AND REMOVED THE BROKEN DRILL TIP WHILE LOCATING THE DEBRIS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383276 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036013165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention