BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35

    MDR report key: 6646375 · Received June 16, 2017

    Report

    Report Number
    3005180920-2017-00316
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 16, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 25 MAY 2017 AND INCLUDES: THE SURGERY WAS ONLY DELAYED BY A FEW MINUTES. BATCH REVIEW PERFORMED ON 12 JUNE 2017. LOT 163595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. THE SURGEON BELIEVED THE EVENT IS DUE TO THE POOR DESIGN OF OUR DRILL GUIDE. HE THINKS THE GUIDE DOES NOT ALLOW THE DRILL PIECE TO CENTRE ITSELF THROUGH THE HOLE IN THE CUP. HE EXPLAINED THAT IT DOESN'T SIT INTO THE CUP FAR ENOUGH WHICH LEADS TO THE DRILL HOLE NOT CENTRALISING DURING DRILLING. ON 14 JUNE 2017, THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE EVENT DESCRIPTION AND THE SURGEON'S STATEMENT, REPORTING AS FOLLOWS: ACCORDING TO THE SURGEON OPINION, THE SCREW BREAKAGE WAS CAUSED OF THE DRILL GUIDE DESIGN, BECAUSE IT DOES NOT ALLOW THE DRILL PIECE TO CENTRE ITSELF THROUGH THE HOLE IN THE CUP. WE DO NOT HAVE MORE INFORMATION OR IMAGES TO COMPLETELY VERIFY THE SURGEON VIEWPOINT. THIS IS THE FIRST TIME THAT WE RECEIVED A FEEDBACK OF THIS TYPE ON DRILL GUIDES. HOWEVER, A NEW DRILL GUIDE HAS BEEN DEVELOPED.

    Description of Event or Problem · 1

    DURING SURGERY THE HEAD OF A 35MM SCREW SNAPPED OFF DURING FINAL TIGHTENING OF THE SCREW. THE REMAINING SCREW WAS LEFT IN PLACE. NO PATIENT HARM OCCURED AND THE CASE WAS COMPLETED SUCCESSFULLY. THE BROKEN PIECE WILL NOT BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428397 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35 CANCELLOUS BONE SCREW LZO MEDACTA INTERNATIONAL SA 163595

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other