BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1.5X105MM 22MM STP J-NT

    MDR report key: 13093519 · Received December 28, 2021

    Report

    Report Number
    0001032347-2021-00607
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Report Date
    June 1, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW COMPLAINT FILE AND MDR WERE CREATED AS EVENT DATES WERE PROVIDED. THIS EVENT WILL NOW BE REPORTED UNDER 0001032347-2022-00175.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SUGGESTED IMDRF CODE- MECHANICAL (G04) - DRILL. TWO OF ITEM# 01-9198 LOT# 347549 AND ONE OF ITEM# 01-9198 LOT# 184901 WERE RETURNED. FOR ITEM# 01-9198 LOT# 357719 NO PRODUCT WAS NOT RETURNED. VISUAL INSPECTION OF RETURNED ITEMS SHOW THAT THE DRILL BITS HAVE FRACTURED IN THE SHAFT OF THE DRILL BIT AREA TOWARD THE COLLAR AREA END. THE REMAINDER OF THE DRILL BIT WAS NOT RETURNED. NO OTHER INFORMATION CAN BE DETERMINED FROM RETURNED PRODUCT. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) FOR ITEM# 01-9198 LOT# 347549 IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD(S) FOR ITEM# 01-9198 LOT# 184901 IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS ALLEGED THAT THE DOCTOR DID NOT USE THE PRODUCT PROPERLY. HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED AND THIS CANNOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS: ITEM #01-9198, LOT # 347549, DRILL 1.5X105MM 22MM STP J-NT; ITEM #01-9198, LOT # 347549, DRILL 1.5X105MM 22MM STP J-NT; ITEM #01-9198, LOT # 184901, DRILL 1.5X105MM 22MM STP J-NT. REPORT SOURCE: (B)(6). 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: 0001032347-2021-00604, 0001032347-2021-00605, 0001032347-2021-00606.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE DRILL HAS BROKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995051 DRILL 1.5X105MM 22MM STP J-NT FLUTED SURGICAL DRILL BIT, REUSABLE HBE BIOMET MICROFIXATION N/A 357719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10