BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7792621 · Received August 17, 2018

    Report

    Report Number
    0001032347-2018-00555
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PECTUS TABLE TOP BENDER (PART# 01-3906, LOT# 012815L14) WAS VISUALLY EVALUATED. THE BENDER WAS IN MODERATE OVERALL CONDITION, WITH SOME MINOR SCRATCHES ON THE BASE AND WEAR ON THE METAL ON METAL CONTACT SURFACES IN THE JOINT; NO DISCOLORATION WAS OBSERVED. INITIALLY THE PLUNGER WAS STUCK IN ITS DOWN POSITION AND WOULD NOT MOVE AS THE BENDER ARM MOVED. A LITTLE BIT OF FORCE WAS APPLIED TO THE PLUNGER TO MOVE IT UPWARDS TOWARD THE JOINT. THE BENDER WAS THEN FUNCTIONALLY TESTED BY RAISING AND LOWERING THE BENDING ARM. THE BENDER SQUEAKED AND WAS A LITTLE STIFF AS THE PLUNGER MOVED UP AND DOWN WITH THE MOVEMENT OF THE BENDER ARM. THE PRODUCT FUNCTIONED BUT IS LIKELY UNRELIABLE FOR FURTHER USE. THE INTERNAL COMPONENTS WERE ROTATED INSIDE THE ASSEMBLY, WHICH RESULTED IN GALLING ON THE HANDLE CAM AND PLUNGER WHEEL WHERE THE SURFACES COME IN CONTACT AND CAUSE FRICTION DURING HANDLE ACTUATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED 'WARNINGS AND PRECAUTIONS': AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. 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 SECTIONS WERE UPDATED: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, FOLLOW-UP TYPE, DEVICE EVALUATED BY MANUFACTURER , METHOD CODE , RESULTS CODE, CONCLUSIONS CODE AND ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PECTUS BAR BENDER DID NOT WORK WHEN THE DISTRIBUTOR TESTED IT. WHEN PUSHING THE HANDLE THE PISTON DID NOT ENGAGE OR MOVE, THEREFORE THE BAR WOULD NOT HAVE BEEN ABLE TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634005 PECTUS TABLE TOP BENDER PECTUS BAR BENDER HXW BIOMET MICROFIXATION N/A 012815L14

    Patients

    Seq Age Sex Outcome Treatment
    1