BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE

    MDR report key: 7334791 · Received March 13, 2018

    Report

    Report Number
    0001032347-2018-00124
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 12, 2018
    Report Date
    August 6, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A VISUAL INSPECTION OF THE THREE (3) RETURNED DRIVERS SHOWS FAIR OVERALL CONDITION AS THERE ARE SIGNS OF USE INCLUDING SCRATCHES AND DISCOLORATION. OF NOTE, ONE DRIVER 24-1189 LOT # 407790 HAD A 76-0017 TEMPORARY FIXATION SCREW INSERTED IN THE COLLET, WHILE A SECOND DRIVER 24-1189 LOT # 008100 HAD A SP-2379 CONTRA ANGLE DRIVER BLADE INSERTED IN THE COLLET WHEN THEY WERE RETURNED. THE THIRD DRIVER 24-1189 LOT # 820410 WAS NOT RETURNED WITH A SCREW OR BLADE IN THE COLLET. THE 76-0017 TEMPORARY FIXATION SCREW HAS DAMAGE NOTED TO THE THREADS, SHOWING SIGNS OF INSERTION. THE SP-2379 CONTRA ANGLE DRIVER BLADE SHOWS SIGNS OF USE WITH DAMAGE TO THE TIP OF THE BLADE. THE 24-1189 DRIVER LOT # 407790 WITH THE 76-0017 TEMPORARY FIXATION SCREW WAS ABLE TO BE EASILY REMOVED FROM AND INSERTED INTO THE COLLET. THE RETURNED 76-0017 TEMPORARY FIXATION SCREW WAS TESTED WITH THE DRIVER THAT DID NOT HAVE A BLADE OR SCREW IN THE COLLET (24-1189 DRIVER LOT # 820410) AND THIS TOO WAS ABLE TO BE INSERTED INTO AND REMOVED FROM THE COLLET EASILY. THEREFORE, THE PORTION OF THE COMPLAINT THAT TWO (2) 24-1189 90 DEGREE CONTRA ANGLE SCREWDRIVERS HAD BIT 76-0017 CONTRA ANGLE TEMPORARY FIXATION SCREW GET STUCK IN THEM IS UNCONFIRMED. THE 24-1189 DRIVER LOT # 008100 WITH THE SP-2379 CONTRA ANGLE DRIVER BLADE WAS DIFFICULT TO REMOVE FROM THE COLLET AND WAS ONLY ABLE TO BE DONE AFTER DISASSEMBLY OF THE DRIVER. THE PORTION OF THE COMPLAINT THAT ONE (1) 24-1189 90 DEGREE CONTRA ANGLE SCREWDRIVER HAD A SP-2379 CONTRA ANGLE T1 BLADE, X-DRIVE GET STUCK IS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE MANUFACTURERS INSPECTION METHODS. THE SUPPLIER USED BLADES, AND NOT THE MIN/MAX GAGE, TO DESIGN THE COLLET RESULTING IN THE COLLET FAILING THE MAX GAGE INSPECTION. BASED ON THE MANUFACTURING DATE OF THE THREE (3) CONTRA ANGLE DRIVERS, THIS ROOT CAUSE IS APPLICABLE TO THE THREE (3) CONTRA ANGLE DRIVERS. 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: 0001032347-2018-00123-2, 0001032347-2018-00188-1, AND 0001032347-2018-00189-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER, CATALOG #: 24-1189, LOT #: NI. THERAPY DATE: (B)(6) 2018. 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 REPORT: 0001032347-2018-00123.

    Description of Event or Problem · 1

    IT WAS REPORTED A CONTRA ANGLE DRIVER HAD BITS STUCK. THERE WAS NO INJURY TO THE PATIENT AND A DELAY OF APPROXIMATELY FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED USING BACK-UP INSTRUMENTS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178342 RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE TEMPORARY FIXATION SCREW HRS BIOMET MICROFIXATION N/A 636820

    Patients

    Seq Age Sex Outcome Treatment
    1