BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS BAR BENDER

    MDR report key: 6206162 · Received December 27, 2016

    Report

    Report Number
    0001032347-2016-00779
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE INSTRUMENT WAS VISUALLY EVALUATED AND SHOWS EXTENSIVE SIGNS OF USE. THERE IS EXTENSIVE CORROSION VISIBLE ON THE ENTIRE INSTRUMENT. ONE OF THE ROLLER PINS HAS BEEN FRACTURED AT THE STEP OF THE SMALLER DIAMETER, WHERE THE GREATEST STRESS WOULD BE SEEN. THE COMPLAINT IS CONFIRMED AS THE ROLLER PIN IS FRACTURED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED TO THE INSTRUMENT DURING USE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WING OF A PECTUS BAR BENDER BROKE OFF DURING SURGERY. IT IS REPORTED, "THE BROKEN PIECE SHOT ACROSS THE ROOM." IT IS REPORTED BOTH PIECES WERE COLLECTED. IT IS REPORTED THE SURGERY WAS COMPLETED WITH ANOTHER PECTUS BAR BENDER SET. IT IS REPORTED THE EVENT CAUSED A FIFTEEN MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855538 PECTUS BAR BENDER BENDER HXW BIOMET MICROFIXATION N/A 519342

    Patients

    Seq Age Sex Outcome Treatment
    1