BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA-C FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X)

    MDR report key: 5353855 · Received January 8, 2016

    Report

    Report Number
    3005180920-2015-00367
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 10, 2015
    Report Date
    May 19, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    PMA / PMN Number
    K140361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 19 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 18 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JANUARY 2016: LOT 141367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 05.JAN.2016 THE SALES REPORTED AS FOLLOWS: "THE SCREW BROKE IN ONLY ONE PIECE AND IT WAS RETRIEVED. ACCORDING TO THE SURGEON, NO PIECE REMAINED INTO THE PATIENT. THERE WAS ONLY MINOR DELAY IN ORDER TO REMOVE THE BROKE PART AND REPLACE THE SCREW WITH A NEW ONE." ON 08 JAN 2016 THE R&D MANAGER CHECKED THE PICTURES OF THE SCREW COMMENTING AS FOLLOWING: THE PICTURES RECEIVED CLEARLY SHOWED THE FAILURE MODE OF THE IMPLANT, WHICH OCCURS AT THE IMPLANT-INSTRUMENT INTERFACE. IN ORDER TO PREVENT SUCH A FAILURE, WHICH ARE MAINLY DUE TO AN EXCESSIVE TORQUE EXERTED FOR FINAL SCREW POSITIONING , ADDITIONAL INSTRUMENTS ARE DEVELOPED. NOT YET RECEIVED.

    Description of Event or Problem · 1

    DURING INSERTION OF ONE OF THE MECTA-C FIXED SELF-DRILLING SCREW WITH THE SELF-RETAINING SCREWDRIVER, THE HEAD OF THE SCREW BROKE. THE SCREW WILL BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13417 MECTA-C FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X) SPINAL FIXATION SCREW KWQ MEDACTA INTERNATIONAL SA 141367

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other