BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1.5X105MM 22MM STP J-NT

    MDR report key: 12008773 · Received June 16, 2021

    Report

    Report Number
    0001032347-2021-00333
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H10 D4: 6 POSSIBLE LOTS WERE FOUND FROM THE VENDOR LOT, IT IS ONE OF THE FOLLOWING: ITEM#: 01-9198, LOT#: 005450 MANUFACTURE DATE: JAN 27, 2021 UDI: (B)(4) 510K: K062842, FDA PROD CODE: HBE ITEM#: 01-9198, LOT#: 011850 MANUFACTURE DATE: SEP 30, 2020 UDI: (B)(4) 510K: K062842, FDA PROD CODE: HBE ITEM#: 01-9198, LOT#: 077800 MANUFACTURE DATE: OCT 18, 2020 UDI: (B)(4) 510K: K062842, FDA PROD CODE: HBE ITEM#: 01-9198, LOT#: 520190 MANUFACTURE DATE: AUG 14, 2020 UDI: (01)00841036016982(10)520190 510K: K062842, FDA PROD CODE: HBE ITEM#: 01-9198, LOT#:709740 MANUFACTURE DATE: DEC 21, 2020 UDI: (B)(4) 510K: K062842, FDA PROD CODE: HBE ITEM#: 01-9198, LOT#: 910220 MANUFACTURE DATE: SEP 22, 2020 UDI: (B)(4) 510K: K062842, FDA PROD CODE: HBE THE DRILL 1.5X105MM 22MM STP J-NT (ITEM# 01-9198, LOT# 355541) WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE '355541' 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 ARE 6 POSSIBLE ZIMMER BIOMET LOTS: 005450, 011850, 077800, 520190, 709740, OR 910220. 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 RELATED TO THIS EVENT. 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 2.0 TROCAR HANDLE CAT# 20-1140 LOT# 327250, 2.0MM DRILL GUIDE SMALL CAT# 24-1126 LOT#NI, CHEEK RETR SEMI RIGID MOD TROC CAT# 01-2556 LOT#NI. MFR SITE:(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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE TROCAR INSTRUMENTATION, THE DRILL BIT COULD NOT DRILL THE PILOT HOLE EASILY AT ALL. THE USER PERSISTED BY USING MORE STRENGTH AND THE DRILL BIT GAVE IN AND BROKE LEAVING A PIECE IN THE PATIENT WHICH THE SURGEON MANAGED TO REMOVE WITH ANOTHER INSTRUMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902843 DRILL 1.5X105MM 22MM STP J-NT FLUTED SURGICAL DRILL BIT, REUSABLE HBE BIOMET MICROFIXATION NI 355541

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR