BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING WRENCH (BRW & CRW)

    MDR report key: 5355411 · Received January 8, 2016

    Report

    Report Number
    1222895-2016-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Report Date
    December 16, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(4) 2015. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: A REVIEW OF THE PFMEA FOR UCHR WAS PERFORMED AND REVEALED THAT THE FAILURE MODE DEPICTED IN THIS COMPLAINT WAS IDENTIFIED AND EVALUATED. THE POTENTIAL RISK RELATED TO THIS COMPLAINT IS CONSIDERED TO BE OF MODERATE SEVERITY. MODERATE BEING THAT THE FAILURE MAY REQUIRE PROFESSIONAL MEDICAL INTERVENTION WITHIN THE STANDARD-OF-CARE, NON-CLINICALLY RELEVANT PROLONGATION OF MEDICAL PROCEDURE / SURGERY, MINOR, TRANSIENT, OR SELF-LIMITING INJURY NOT REQUIRING PROFESSIONAL MEDICAL INTERVENTION OR CANCELLATION OF AN ELECTIVE MEDICAL PROCEDURE / SURGERY. A DHR REVIEW LISTED A TOTAL OF 55 HEAD WRING END CAP DEVICES WERE PRODUCED IN THE SAME LOT WITH LOT CODE: 130339754. NO ABNORMALITIES RELATED TO THE REPORTED INCIDENT WERE FOUND, NOR WERE THERE ANY VARIANCES, MRR OR REWORKS ASSOCIATED WITH THIS LOT ORDER. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. CONCLUSION: THE COMPLAINT DETERMINATION WAS CONFIRMED. THE HEAD RING WRENCH WAS MANUFACTURED UNDER LOT NUMBER 130343672; THE COMPLAINT INDICATED THAT THE HEX WAS UNDERSIZED AND WOULD NOT ALLOW THE HEAD OF THE SCREW TO BE INSERTED INTO THE WRENCH SOCKET. THIS PART IS TO HAVE HEX SHAPED THRU HOLE, WITH THE FLATS MEASURING .219 (-.000/+.003); THE TWO UNITS THAT WERE RETURNED BOTH MEASURED .212 (OR .007¿ ULL). SEE DRAWING BELOW FOR DETAIL. IT IS BELIEVED THE ROOT CAUSE WAS CAUSED BY OPERATOR ERROR TO FULLY INSERT THE BROACH COMPLETELY THROUGH THE END CAP.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATING THE ISSUE WITH THE WRENCHES OCCURRED PRIOR TO USE ON A PATIENT. THE DEVICE EVALUATION AND INVESTIGATION WAS COMPLETED ON (B)(6) 2016; CONCLUSION: IT IS BELIEVED THE ROOT CAUSE WAS CAUSED BY OPERATOR ERROR TO FULLY INSERT THE BROACH COMPLETELY THROUGH THE END CAP.

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE CRW HEADRING AND THE LONG AND SHORT HEADRING SCREWS WERE BEING APPLIED TO THE RING WHICH IS ATTACHED TO THE PATIENTS HEAD. THE WRENCH (HRW - HAND RING WRENCH) THAT IS USED TO TIGHTEN THE HEADRING SCREWS WOULD NOT EVEN FIT OVER EITHER ONE OF THE SCREWS -- THE LONG OR THE SHORT SCREWS. BOTH WRENCHES HAD THIS ISSUE. THE DOCTOR REACHED IN BOX FOR THEIR OLDER HRW AND WAS ABLE TO TIGHTEN THE SCREWS INTO THE PATIENTS HEAD WITH NO ISSUE. THE PROCEDURE WAS BEING PERFORMED AT THE PATIENT'S BEDSIDE AND NOT IN AN OR SUITE. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14333 HEAD RING WRENCH (BRW & CRW) N/A HAW INTEGRA BURLINGTON, MA, INC. 130343672

    Patients

    Seq Age Sex Outcome Treatment
    1