BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7826396 · Received August 29, 2018

    Report

    Report Number
    0001032347-2018-00572
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    July 31, 2018
    Report Date
    January 30, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00666.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT IDENTITIES WERE CONFIRMED. THE ORIGINAL COMPLAINT REPORTED TWO DRIVERS WITH ONE FIXATION PIN AND ONE BLADE GETTING STUCK INSIDE. HOWEVER, THE TWO DRIVERS WERE RETURNED WITH TWO FIXATION SCREWS STUCK INSIDE. THE 90° CONTRA ANGLE DRIVERS (PART# 24-1189, LOT# 267770, 593680) WERE RETURNED WITH RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE (PART# 76-0017, LOT# 106440, UNK) STUCK INSIDE. THE TWO DRIVERS APPEARED TO BE IN GOOD CONDITION OVERALL. FUNCTIONAL TESTING WAS DONE BY ATTEMPTING TO REMOVE THE SCREWS FROM THE DRIVERS. THE SCREWS COULD NOT BE REMOVED, THEREFORE THE COMPLAINT IS CONFIRMED. THE DRIVERS WERE DISASSEMBLED FOR FURTHER INSPECTION. WHEN THE COVER OF THE HEAD ASSEMBLY WAS REMOVED FROM THE DRIVER (LOT# 267770), IT WAS NOTED THAT THE SCREW (LOT# 106440) HAD ROTATED INSIDE THE DRIVER COLLET AND COULD NOT BE REMOVED WITHOUT BEING ROTATED PRIOR TO PULLING IT OUT. WEAR WAS OBSERVED ON THE MATING SURFACES OF THE SCREW AND THE DRIVER COLLET. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THAT EXCESSIVE TORQUE WAS APPLIED, BEYOND WHAT IS REQUIRED TO SEAT THE SCREW. THE EXCESSIVE TORQUE WORE DOWN THE SCREW AND COLLET, THEN CAUSED THE COLLET TO ROTATE AROUND THE SCREW. THE INSTRUCTIONS FOR USE (IFU) FOR THESE PRODUCTS STATES IN THE SECTION TITLED 'WARNINGS AND PRECAUTIONS': AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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: 0001032347-2018-00573, 0001032347-2018-00666, AND 0001032347-2019-00062.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE, CATALOG #: 76-0017, 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 REPORTS: 0001032347-2018-00573.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO CONTRA ANGLE DRIVERS MALFUNCTIONED DURING A RIB FIXATION PROCEDURE. ONE OF THE DRIVERS PERMANENTLY RETAINED THE TEMPORARY FIXATION SCREW. THE PROCEDURE WAS COMPLETED USING BACKUP DRIVERS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672054 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 267770

    Patients

    Seq Age Sex Outcome Treatment
    1