BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS BAR BENDER

    MDR report key: 7999160 · Received October 24, 2018

    Report

    Report Number
    0001032347-2018-00691
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 24, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    K972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PECTUS BAR BENDER WAS VISUALLY EVALUATED. THE BENDER SHOWED SIGNS OF MODERATE USE WITH MINOR WEAR ON THE HANDLE GRIPS, SCRATCHING ON THE ELLIPTICAL ROLLER, AND THE PIN FOR THE ROLLER ON THE FEMALE BENDER ARM HAD SHEARED OFF AT THE POINT WHERE THE ROLLER INTERFACES WITH THE BENDER ARM. THE PIN EXPERIENCES STRESS AT THIS POINT WHEN THE HANDLES ARE ACTUATED TO BEND A BAR. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE DEVICE EXPERIENCED EXCESSIVE FORCE, BEYOND WHAT IT WAS DESIGNED TO ENCOUNTER.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.A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: BASED ON THE SERIAL NUMBER PROVIDED THE POTENTIAL LOT NUMBERS ARE 212380, 401400, 539680, 684990, AND 627190. UNIQUE IDENTIFIER (UDI) #: (B)(4). (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE BENDING THE PECTUS BAR ON THE INSTRUMENT TABLE, THE FORWARD PIN BROKE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843164 PECTUS BAR BENDER BENDER HXW BIOMET MICROFIXATION N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1