BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES

    MDR report key: 2410614 · Received January 4, 2012

    Report

    Report Number
    1836161-2011-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    August 16, 2011
    Report Date
    December 1, 2011
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    GES
    PMA / PMN Number
    PREAMEND
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE OF THIS PRODUCT WAS NOT ORIGINALLY GOING TO BE RETURNED SO THE INVESTIGATION WAS COMPLETED WITH NO PRODUCT SAMPLE. THE SAMPLE PRODUCT WAS EVENTUALLY RETURNED AND THE INVESTIGATION WAS REOPENED. THIS FAILURE IS ATYPICAL. TWO PIECES OF THE BROKEN BLADE WERE RETURNED AND TESTED FOR HARDNESS AND DUCTILITY AND MET ALL SPECS. CONDITION COULD BE DUE TO MISUSE. ADD'L INFO FROM U/F REPORT # (B)(4). COMMON DEVICE NAME: BARD PARKER BLADE; MODEL: #11 KNIFE BLADE; LOT # 0000234.

    Description of Event or Problem · 1

    (B)(4). ADD'L INFO FROM USER FACILITY REPORT: THE PT IS A (B)(6) MALE ADMITTED TO THE MEDICAL CENTER FOR A SCHEDULED RIGHT SHOULDER ROTATOR CUFF REPAIR. DURING THE PROCEDURE THE SCALPEL BLADE BROKE AT IT'S BASE. THE BROKEN PORTION OF THE BLADE WAS VISIBLE IN THE SUBACROMIAL SPACE. IN REMOVING THE BROKEN BLADE THE VERY TIP OF THE BLADE ALSO BROKE OFF. THE TIP PORTION COULD NOT BE VISUALIZED SO AN X-RAY WAS ORDERED. THE X-RAY DID SHOW THE BROKEN TIP IN THE POSTERIOR MUSCLE. IT WAS DECIDED TO LEAVE THE RETAINED TIP IN THE MUSCLE AS IT WAS FELT THAT REMOVAL WOULD POSE MORE RISK THAN LEAVING IT IN. THE PT AND HIS WIFE WERE MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES BARD PARKER RIB BACK, 311, STERILE GES ASPEN SURGICAL PRODUCTS 371111 0000234

    Patients

    Seq Age Sex Outcome Treatment
    1