BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE

    MDR report key: 7288905 · Received February 22, 2018

    Report

    Report Number
    1836161-2018-00021
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    December 15, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A NOTIFICATION LETTER FROM THE FDA INDICATING THAT MEDWATCH REPORT NUMBER MW5074502 WAS SUBMITTED FROM THE END USER OF A BARD-PARKER BLADE. IN THIS REPORT, THE END USER INDICATED THAT NO SAMPLE WAS AVAILABLE FOR EVALUATION, ONLY THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. DURING RIGHT SHOULDER SURGERY, A BARD PARKER SIZE 11 BLADE BROKE. THE BROKEN PIECE WAS LOCATED IN THE SUBACROMIAL REGION. THE SURGEON REMOVED THE BROKEN BLADE PIECE IN ITS ENTIRETY WITHOUT INCIDENT IN AN ARTHROSCOPIC PROCEDURE. THE PATIENT TOLERATED WELL AND FOLLOW UP CARE WAS NOT REQUIRED. BASED ON THE EVALUATION CONDUCTED, LOT 0050683 WAS PACKED PER DHR AND NO NON-CONFORMANCE RELATED TO THE BROKEN BLADE WERE PRESENT. PACKING PROCESS HAS ESTABLISHED CONTROLS TO MITIGATE BROKEN BLADE CONDITION, INCLUDING A BLADE SENSOR THAT INSPECT 100% OF PACKED POUCHES LINER LEVEL PRIOR TO ALUMINUM FOIL PACKAGING. THE FOLLOWING CONTROLS ARE IN-PLACE TO MITIGATE ¿BROKEN BLADE¿ CONDITION AT ASPEN SURGICAL LAS PIEDRAS SITE: HEAT TREATMENT IN-PROCESS AT THE BEGINNING AND END OF EACH LOT ARE INSPECTED FOR DIMENSION INTEGRITY USING A PIN GAUGE, FLATNESS GAUGE AND PERFORATION LENGTH GAUGE, DUCTILITY TEST, AND HARDNESS TEST. HEAT TREATMENT QUALITY INSPECTIONS AT THE BEGINNING AND END OF EACH LOT ARE INSPECTED FOR DIMENSION INTEGRITY USING A PIN GAUGE, FLATNESS GAUGE AND PERFORATION LENGTH GAUGE, DUCTILITY TEST, AND HARDNESS TEST. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A LETTER FROM THE FDA INDICATING THAT A CUSTOMER SUBMITTED A MEDWATCH REPORT DUE TO A BARD-PARKER BLADE THAT BROKE OFF IN PATIENT DURING A PROCEDURE. THE INCIDENT OCCURRED AT THE USER FACILITY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132775 BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE BARD-PARKER BLADE GES ASPEN SURGICAL PRODUCTS, CALEDONIA 371111-150 0050683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R