BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF SCREWDRIVER UNIVERSAL JOINT

    MDR report key: 5369900 · Received January 15, 2016

    Report

    Report Number
    3005180920-2015-00389
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 17, 2015
    Report Date
    March 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 JAN 2016, IT WAS CONFIRMED THAT ALL OF THE PIECES THAT FELL IN THE PATIENT WERE REMOVED. ON 15 JANUARY THE R&D PROJECT MANAGER MADE A PRELIMINARY INVESTIGATION CHECKING THE PICTURES RECEIVED: THE TIP (TORX T20) OF THE SCREWDRIVER IS BROKEN. THE FUNCTIONALITY OF THE ALIF SCREWDRIVER UNIVERSAL JOINT TO INSERT AND TEMPORARY FIX THE SCREW INTO THE PLATE IS COMPROMISED. THE MEAN FAILURE OF THE TORX T20 OCCURS WITH TORQUE HIGHER THAN 9NM. THE MAXIMUM TORQUE THAT CAN BE APPLIED ON THE SCREW ACCORDING THE SURGICAL TECHNIQUE IS 5.5NM+/-10%. THE ALIF SCREWDRIVER BUSH IS DEFORMED. THE FUNCTIONALITY OF THE ALIF SCREWDRIVER UNIVERSAL JOINT TO RETAIN THE SCREW IS COMPLETELY COMPROMISED. THE DEFORMATION OF THE ALIF SCREWDRIVER BUSH AND BREAKAGE OF THE TIP (TORX T20) OF THE SCREWDRIVER CAN BE CAUSED BY THE APPLICATION OF AN UNCONTROLLED TORQUE ON THE SCREW DURING INSERTION. BATCH REVIEW PERFORMED ON 15 JANUARY 2016: LOT 1410920: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) SIMILAR EVENTS REPORTED ON ITEMS OF THE SAME LOT WITHIN MDR 2015-00157 AND MDR 2015-00338. MECTALIF ANTERIOR SCREW DIAM.5X25 (DOUBLE PACKAGING) CODE 03.30.121 LOT. 140625 (K124034): LOT 140625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 AUGUST 2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 02 MARCH 2016, THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE TIP (TORX T20) OF THE SCREWDRIVER IS BROKEN. THE FUNCTIONALITY OF THE ALIF SCREWDRIVER UNIVERSAL JOINT TO INSERT AND TEMPORARY FIX THE SCREW INTO THE PLATE IS COMPROMISED. THE ALIF SCREWDRIVER BUSH IS DEFORMED. THE MEAN FAILURE OF THE TORX T20 OCCURS WITH TORQUE HIGHER THAN 9NM. THE MAXIMUM TORQUE THAT CAN BE APPLIED ON THE SCREW ACCORDING THE SURGICAL TECHNIQUE IS 5.5NM+/-10%. THE BREAKAGE OF THE TIP (TORX T20) OF THE SCREWDRIVER MAY HAVE BEEN CAUSED BY THE APPLICATION OF AN UNCONTROLLED TORQUE OR LATERAL BENDING ON THE SCREW DURING INSERTION. THE SAME ROOT CAUSE CAN BE MENTIONED FOR THE DEFORMATION OF THE ALIF SCREWDRIVER BUSH. ON 21 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THE INITIAL AND IN THE CURRENT REPORTS. ON 23 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON WAS INSERTING THE SCREW AND THE PATIENT MOVED. THE MOVEMENT CHANGED THE POSITION OF THE SCREWDRIVER IN THE PATIENT AND THE SURGEON COULD NOT RELEASE THE SCREWDRIVER. THE TIP OF THE SCREWDRIVER BROKE OFF AND THE SCREW STRIPPED. THE SALES AGENT HAD ANOTHER SCREWDRIVER AND SCREW THAT WAS USED TO COMPLETE THE SURGERY. THE INSTRUMENT WILL BE RETURNED TO MEDACTA (B)(4). THERE ARE NO X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28655 ALIF SCREWDRIVER UNIVERSAL JOINT SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1410920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other