BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRW PRECISION ARC SYSTEM

    MDR report key: 4608459 · Received March 13, 2015

    Report

    Report Number
    1222895-2015-00015
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATIO HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/16/2015. EVAL RESULTS: THE COMPLAINT WAS CONFIRMED BUSHING ATTACHED TO DRILL BIT AND CAN'T BE REMOVED. DHR REVIEW CANNOT BE PERFORMED AT THIS TIME AS THE LOT OR SERIAL NUMBER WAS NOT ETCHED ON THE RECEIVED PART. A TWO YEAR LOOK BACK IN TRACKWISE FOR THIS REPORTED FAILURE AND OR RELATED TO "BUSHING ATTACHED TO THE BIT AND COULD NOT REMOVE" FOR THIS PRODUCT ID SHOWS THAT NO ADD'L COMPLAINTS WERE RECEIVED. NO NEW DESIGN OR MFG TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: ROOT CAUSE IS USER ERROR. THE INCORRECT SIZE BUSHING WAS USED WITH THE DRILL BILL. A SMALLER SIZE BUSHING SHOULD HAVE BEEN USED.

    Description of Event or Problem · 1

    WHEN THE 3..2 DRILL BIT WAS PUT THROUGH THE 3.2 REDUCING TUBE AND BUSHING, THE BUSHING CAUGHT ON THE DRILL BIT AND WOULDN'T GO FURTHER RIGHT AS IT HIT THE BONE. THE BUSHING WAS NOW ATTACHED TO THE BIT AND COULD NOT BE REMOVED. THE CAUSE WAS DELAYED FOR NEARLY 30 MINUTES. AS PER THE INTEGRA SALES REPRESENTATIVE, NO PATIENT INJURY OCCURRED TO HIS KNOWLEDGE. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2015, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER: THE PROBLEM OCCURRED AT THE START OF THE SURGICAL CASE. THE DRILL WAS CHECKED TO MAKE SURE THE BIT FIT. IT WENT THROUGH THE BUSHING AND WAS THEN PLACED ON THE SKULL. ONCE DRILLING STARTED, THE BIT WOULD NOT GO ANY FURTHER. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS 10 SECONDS. THE PATIENT WAS A (B)(6) FEMALE WHO WAS TO UNDERGO A VISUALASE LASER WIRE FOR EPILEPSY. PATIENT HARM/INJURY WAS REPORTED AS "PATIENT WAS UNDER ANESTHESIA FOR AN EXTRA 30 MINUTES". THERE WAS NO PATIENT ADVERSE CONSEQUENCE AS A RESULT OF THE SURGICAL DELAY AS FAR AS THE CUSTOMER WAS AWARE OF. THE BUSHING WAS NOT ABLE TO BE REMOVED FROM THE BIT. THERE WAS A REPLACEMENT BUSHING IN THE SET AND ANOTHER DRILL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173496 CRW PRECISION ARC SYSTEM STEREOTAXY HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other