BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 45

    MDR report key: 6556717 · Received May 10, 2017

    Report

    Report Number
    3005180920-2017-00240
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 10, 2017
    Report Date
    May 10, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 APRIL 2017 AND INCLUDES: CARDAN HEX-HEAD SCREWDRIVERS 3.5MM WAS USED DURING SURGERY. THIS ISSUE CAUSED A DELAY OF 20 MINUTES. BATCH REVIEWS PERFORMED ON 08 MAY 2017. LOT 135327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. 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. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35, CODE 01.26.65.35, LOT. 163595 (K103352). APPROX (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.

    Description of Event or Problem · 1

    IT WAS IMPOSSIBLE TO PUT A THE SCREW INTO THE CUP DURING SURGERY. THE SURGEON SAID THAT THE PROBLEM WAS THE SCREW. HE TRIED TO USE 2 DIFFERENT SCREWDRIVERS, THEN HE CHANGED THE SCREW. DESPITE THAT, HE COULDN'T INSERT THE SCREW. THE SURGEON USED ANOTHER COMPANY SCREW AND COMPLETED THE SURGERY SUCCESSFULLY. THIS ISSUE CAUSED A DELAY OF 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337501 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 45 CANCELLOUS BONE SCREW LZO MEDACTA INTERNATIONAL SA 135327

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other