BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 8173768 · Received December 18, 2018

    Report

    Report Number
    0001032347-2018-00867
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Report Date
    February 28, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 981670) WAS RETURNED WITH A CONTRA ANGLE TEMPORARY FIXATION SCREW (PART# 76-0017, LOT# 636820) IN THE COLLET. THE DRIVER SHOWED SIGNS OF MODERATE USE WITH SOME MINOR DISCOLORATION ON THE HANDLE AND KNOB, LIKELY FROM REPEATED AUTOCLAVE CYCLES. THE DRIVER WAS FUNCTIONALLY TESTED BY ATTEMPTING TO REMOVE THE TEMPORARY FIXATION SCREW. THE SCREW COULD NOT BE REMOVED. THE DRIVER WAS DISASSEMBLED FOR FURTHER INVESTIGATION. THE SCREW WAS FOUND TO BE NOT FULLY INSERTED INTO THE COLLET UPON REMOVING THE COVER FROM THE HEAD ASSEMBLY. THE SCREW WAS DIFFICULT TO PUSH OUT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. 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. THE FOLLOWING SECTION WAS CORRECTED: LOT NUMBER WAS CORRECTED FROM 172350 TO 981670. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00868-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). UNIQUE IDENTIFIER (UDI) #: (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE CATALOG #: 76-0017 LOT #: NI. THERAPY DATE: UNKNOWN. 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: 0001032347-2018-00868.

    Description of Event or Problem · 1

    IT WAS REPORTED A TEMPORARY FIXATION PIN IS STUCK IN THE DRIVER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014046 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 981670

    Patients

    Seq Age Sex Outcome Treatment
    1