BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP

    MDR report key: 12445961 · Received September 9, 2021

    Report

    Report Number
    0001032347-2021-00422
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 5, 2021
    Report Date
    December 7, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE LOT NUMBER #336380 ETCHED ON THIS PRODUCT IS THE SUPPLIER LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS, THERE ARE FOUR POSSIBLE LOTS: 030770, 296160, 714300, 893900, 893950, OR 894080. ONE (1) TW DRILL 1.1X50MM 15MMSTP W/NT (ITEM# 01-7148, LOT# 335380) WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED FRACTURE, AS THE DRILL WAS BROKEN NEAR THE START OF THE FLUTED SECTION. VISUAL EXAMINATION ALSO CONFIRMED THE DEVICE'S PART AND LOT NUMBER. THE FRACTURED TIP OF THE DRILL WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF THE END LEVEL DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE THE RECORDS ARE RELATED TO PACKAGE AND LABEL ONLY AND THE REPORTED EVENT IS NOT ASSOCIATED WITH PACKAGING OR LABELING. THE SUPPLIER DHR WAS NOT REQUESTED BECAUSE THE RAW MATERIAL CERTIFICATE SHOWED THE MATERIAL IS CONFORMING TO SPECIFICATION, INCLUDING THE MATERIAL HARDNESS. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE POTENTIAL PART AND LOT COMBINATIONS. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE:(B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE 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 THE DRILL TIP BROKE DURING SURGERY AND WAS LEFT IN THE PATIENT. A DELAY OF THIRTY MINUTES OR MORE WAS NOTED. THE SURGEON ATTEMPTED TO SEARCH AND COULD NOT FIND ON THE X-RAY SO THE INCISION WAS CLOSED. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR REMOVAL OF THE PLATE AND RE FIXATION ON THE NEXT DAY TO REMOVE THE BROKEN TIP WHICH WAS CONFIRMED ON THE CT SCAN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344474 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R