BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS BAR BENDER

    MDR report key: 7189029 · Received January 15, 2018

    Report

    Report Number
    0001032347-2018-00028
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 4, 2017
    Report Date
    June 21, 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 PRODUCT WAS VISUALLY EVALUATED AND IT WAS FOUND THAT THE ROLLER PIN ON THE FEMALE BENDER ARM HAS FRACTURED. THERE WERE SCRATCHES AND NORMAL SIGNS OF WEAR ON THE INSTRUMENT; SOME DISCOLORATION WAS OBSERVED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE COMPLAINT WAS CONFIRMED AS ONE OF THE ROLLER PINS ON THE INSTRUMENT HAS FRACTURED. THE PIN HAS A SHEAR FRACTURE BETWEEN WHERE THE ROLLER AND BENDER ARM INTERFACE. THE PIN EXPERIENCES STRESS AT THIS POINT WHEN THE HANDLES ARE ACTUATED TO BEND A BAR. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT IT IS STATED ¿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.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT AND UDI # AND MANUFACTURING DATE: BASED ON THE NUMBER (052086) ETCHED ON THE INSTRUMENT AND A COMPARISON OF THE ACCOUNT'S PURCHASE HISTORY, THERE ARE FIVE (5) POSSIBLE LOT NUMBERS, UDI NUMBERS, AND MANUFACTURING DATE: LOT: 372900, (B)(4), MANUFACTURED: AUG 30, 2013. LOT: 307010, (B)(4), MANUFACTURED: AUG 26, 2013 LOT: 914170, (B)(4), MANUFACTURED: OCT 25, 2013. LOT: 446890, (B)(4), MANUFACTURED: DEC 12, 2013. LOT: 308560, (B)(4), MANUFACTURED: DEC 02, 2013. (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 THAT DURING A STERNAL PROCEDURE, "THE ROLLER PIN OF LEFT SIDE CAME OFF WHEN THE SURGEON ATTEMPTED TO BEND THE PECTUS BAR DURING A SURGERY. A SURGERY WAS COMPLETED USING ANOTHER ONE OF THE BACK UP AND A SURGERY DELAY WAS UNKNOWN." THE MEDICAL PROFESSIONAL DID NOT INDICATE HARM OR INJURY TO PATIENT/ OPERATOR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33350 PECTUS BAR BENDER PECTUS BAR BENDER HXW BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1