BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7826955 · Received August 29, 2018

    Report

    Report Number
    0001032347-2018-00586
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLES WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE FIVE (5) 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189) WERE VISUALLY EVALUATED. THERE WAS ONE (1) DRIVER FROM LOT# 252610, ONE (1) FROM LOT# 270660, TWO (2) FROM LOT# 023440, AND ONE (1) FROM LOT# 488010. ALL DRIVERS SHOWED SIGNS OF MODERATE USE WITH SOME DISCOLORATION AND GENERAL HANDLING COSMETIC DAMAGE. ALL DRIVERS WERE FUNCTIONALLY TESTED BY ROTATING THE KNOB IN BOTH THE CLOCKWISE AND COUNTER-CLOCKWISE DIRECTIONS, AND WERE FOUND TO BE TOUGH TO TURN AND FREQUENTLY STICKING DURING ROTATION. THE DRIVERS FROM LOT#'S 252610 AND 270660 ALSO HAD BLADES STUCK INSIDE THE COLLETTS THAT COULD NOT BE REMOVED. THE DRIVERS WERE DISASSEMBLED FOR FURTHER INSPECTION AND ALL WERE FOUND TO HAVE STRIPPED INTERNAL GEARS AND METAL SHAVINGS FELL OUT OF EACH DURING DISASSEMBLY. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED FOR EACH LOT AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT THE DRIVERS WERE STICKING WAS DUE TO THE GEARS BEING STRIPPED, LIKELY RESULTING FROM TORQUE IN EXCESS OF WHAT IS REQUIRED TO FIXATE THE SCREW. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT THE BLADES BEING STUCK IN THE DRIVER WAS DUE TO THE CONNECTION ISSUES DUE TO THE SUPPLIER USING BLADES, AND NOT THE MIN/MAX GAGE, TO DESIGN THE COLLET RESULTING IN THE COLLET FAILING THE MAX GAGE INSPECTION. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT IT IS STATED AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. THE DISCOLORATION IS MOST LIKELY DUE TO RESIDUAL FROM THE CLEANING PROCESS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00583-1, 0001032347-2018-00584-1, AND 0001032347-2018-00585-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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: 0001032347-2018-00583, 0001032347-2018-00584, AND 0001032347-2018-00585.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRIVERS ARE STICKING. THE ISSUES WERE IDENTIFIED WHILE THE DISTRIBUTOR WAS CHECKING SETS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671743 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 488010

    Patients

    Seq Age Sex Outcome Treatment
    1