BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7761582 · Received August 8, 2018

    Report

    Report Number
    0001032347-2018-00531
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 6, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE CUSTOMER INITIALLY REPORTED AN INCORRECT LOT NUMBER. BASED ON THE CUSTOMER'S SALES HISTORY THERE ARE TWO POSSIBLE LOTS. LOT 033115C15 MANUFACTURE DATE 4/6/2015. LOT 091015C15 MANUFACTURE DATE 9/15/2015. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT. SERIAL NUMBER. DEVICE AVAILABILITY . DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT AND FOLLOW-UP NUMBER FOLLOW-UP TYPE. DEVICE EVALUATED BY MANUFACTURER . THE FOLLOWING SECTIONS WERE CORRECTED: LOT NUMBER CORRECTED FRO 061014E14 TO SEE H10 NARRATIVE AS THERE ARE TWO POSSIBLE LOTS DEVICE MANUFACTURE DATE CORRECTED FROM JUN 10, 2014 TO BLANK FIELD AS THERE ARE TWO POSSIBLE DATES.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE PECTUS TABLE TOP BENDER (PART# 01-3906, LOT# UNK) SHOWED SIGNS OF MODERATE WEAR. THERE WAS TYPICAL WEAR AND TEAR FROM NORMAL USE WITH SCRATCHES AROUND THE JOINT AREA. THE PLUNGER ON THE BENDER WAS STUCK IN POSITION, PREVENTING THE ANVIL FROM MOVING WHEN THE HANDLE WAS ACTUATED. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED FOR THE TWO POSSIBLE LOTS 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. 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: ETHNICITY, 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). 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 THE BENDER STOPPED FUNCTIONING PROPERLY. WHILE THE SURGEON WAS COMPLETING THE FINAL BEND ON A PECTUS BAR DURING THE CASE, THE SPRING IN THE TABLE TOP BENDER "WORE OUT" AND THE HANDLE WOULD NO LONGER FUNCTION. THE SURGEON USED A HANDHELD BENDER TO COMPLETE THE BEND. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605076 PECTUS TABLE TOP BENDER PECTUS BAR BENDER HRS BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1