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: 11121464 · Received January 5, 2021

    Report

    Report Number
    0001032347-2021-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 10, 2020
    Report Date
    July 16, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013189
    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. D10: ITEM# 915-1595 LOT# COULD BE 740230, 978400, 240790, 240800, 312840, 886060, 041940, 161330, 442760, 645150, 645160.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE TW DRILL 1.1X50MM 9MMSTOP W/NT (ITEM# 01-7146, LOT# 157392) WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE '157392' ETCHED ON THE BODY OF THIS DRILL IS THE VENDOR'S LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE IS 1 POSSIBLE ZIMMER BIOMET LOT: 250370. VISUAL EXAMINATION OF THE RETURNED DRILL AND TAP CONFIRMED THE PRODUCTS' IDENTITY. IT WAS ALSO CONFIRMED THAT THE DRILL AND TAP WERE 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 FOR THE DRILL 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00007. CONCOMITANT MEDICAL PRODUCTS 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP, PART# 01-7146, LOT# NI. LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP, PART# 915-1595, LOT# NI. 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 TAP BROKE WHILE THE SURGEON WAS CUTTING THE TAP RESULTING IN A SURGICAL DELAY GREATER THAN THIRTY MINUTES. THE SURGEON DRILLED A HOLE AROUND THE BROKEN TAP WITH A TWIST DRILL AND USED PLIERS TO REMOVE THE TAP. IMAGING REVEALED THERE WAS NO FRAGMENT IN THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17862 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 250370 00841036013189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention