BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7512529 · Received May 14, 2018

    Report

    Report Number
    0001032347-2018-00270
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    March 10, 2018
    Report Date
    October 24, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CONFIRMED. THE BENDER WAS VISUALLY INSPECTED. THE BENDER SHOWED SIGNS OF MODERATE WEAR, WITH SOME SCRATCHING ON THE HANDLE AND THE BASE. THE ADJUSTABLE KNOB WAS STUCK IN PLACE AND COULD NOT ADJUST THE HEIGHT OF THE ANVIL. THE BENDER WAS FUNCTIONALLY TESTED BY BENDING A PECTUS SUPPORT BAR AND THE BENDING MOVEMENT FELT A BIT STIFFER THAN NORMAL, WITH A SQUEAKING NOISE DURING ROTATION. THERE WERE ALSO SIGNS OF WEAR AT THE METAL ON METAL ROTATIONAL JOINT BETWEEN THE BENDING ARM AND THE ANVIL. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS FOR THIS PRODUCT. DEVICE HISTORY RECORDS (DHR'S) FOR THE POTENTIAL LOTS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO NORMAL WEAR AFTER EXTENSIVE USE. 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 REPORT IS BEING SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF THE DEVICE IT WAS IDENTIFIED THE PART IS ETCHED G16. BASED ON THE CUSTOMER INVOICES THERE ARE TWO POSSIBLE LOTS. LOT #: 080816 G16, MANUFACTURE DATE: 8/8/2016. LOT #: 081616 G16, MANUFACTURE DATE: 8/16/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THE "BENDER WAS USED FOR NORMAL PECTUS OPERATION, THE DOCTOR FELT DIFFICULTY TO BEND AFTER LONG TIME USE. SO, THE DOCTOR RETURNED THE BENDER TO CHECK AND WE FOUND THAT THE REQUESTED PART WERE WORN." NO INJURY WAS REPORTED AND THE SURGICAL DELAY IS UNKNOWN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED USING OTHER INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354779 PECTUS TABLE TOP BENDER BENDER HXW BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PECTUS BAR CATALOG #: NI LOT #: NI