BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9NM TORQUE LIMITER SET SCREWDRIVER

    MDR report key: 5322929 · Received December 23, 2015

    Report

    Report Number
    3005180920-2015-00339
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 24, 2015
    Report Date
    March 23, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 BY THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM: THE INSTRUMENT LOOKS IN GOOD CONDITIONS, BOTH ON THE IMPLANT SIDE (HEX KEY) AND ON THE HANDLE INTERFACE. THE INSTRUMENT HAS BEEN TESTED ON A SAMPLE IMPLANT (PEDICLE SCREW+ROD+SETSCREW) TOGETHER WITH A T-HANDLE ((B)(4)) AND A COUNTER TORQUE ((B)(4)) AS PER SURGICAL TECHNIQUE. THE INSTRUMENT WORKS PROPERLY, THE TORQUE LIMITING MODULE SLIPS AND "CLICKS" AS EXPECTED WHEN 9NM TOQUE IS REACHED. EVEN WITH MULTIPLE TIGHTENING ACTIONS THE INSTRUMENT WORKS SMOOTHLY AND BOTH SETSCREW AND PEDICLE SCREW ARE NOT DAMAGED. FROM A DIMENSIONAL AND FUNCTIONAL POINT OF VIEW, THE INSTRUMENT IS CONFORM. IT IS LIKELY THAT THE DESCRIBED EVENT OCCURRED BECAUSE OF A MALPOSITIONING OF THE SETSCREW ON THE PEDICLE SCREW HEAD (MISALIGNMENT). IN SUCH CASES, WHEN THE USER TRIES TO TIGHTEN IT, THE SCREW CROSS-THREADS AND GET DAMAGED BEFORE REACHING THE 9NM, THEREFORE THE WHICH LED TO CROSS THREADING. IN SUCH CASES, THE DRIVER DOESN'T "CLICKS" AND MIGHT APPEAR FAULTY. INSTRUMENTS ARE PROVIDED TO HELP THE SURGEON ACHIEVING A PROPER SETSCREW ALIGNMENT (E.G. ENHANCED SETSCREW DRIVER (B)(4), ONE-STEP REDUCER (B)(4)). AND THE SURGEON SHOULD ALWAYS VERIFY (VISUALLY AND FUNCTIONALLY) IF A SETSCREW IS PROPERLY ALIGNED BEFORE FINAL TIGHTENING. THEREFORE THE EVENT CAN BE DEFINED AS USER ERROR. BATCH REVIEW PERFORMED ON 18 DECEMBER 2015: LOT 1410995: (B)(4) ITEM MANUFACTURED AND RELEASED ON 23 JULY 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. PEDICLE SCREW 6X50 + SET SCREW; CODE (B)(4) LOT. 122869 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2012. EXPIRATION DATE: 2017-06-30. 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

    THE SURGEON HAD DIFFICULTIES DURING THE SURGERY WITH THE TORQUE LIMITER SCREWDRIVER. THIS LEAD TO HIM STRIPPING A PEDICLE SCREW AND TWO SET SCREWS. THE PEDICLE SCREW (03.50.019 LOT 122869) HAD TO BE EXPLANTED AND A NEW ONE WAS USED. ALL OF THE SET SCREWS WERE PUT INTO A CUP SO THE EXACT REFERENCE AND LOT NUMBERS CANNOT BE CONFIRMED. THE SALES AGENT HAD A SECOND TORQUE LIMITER SCREWDRIVER IN THE SET WHICH WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE ARE NO X-RAYS AVAILABLE. THE PRODUCTS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850437 9NM TORQUE LIMITER SET SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1410995

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other