BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN

    MDR report key: 8155032 · Received December 12, 2018

    Report

    Report Number
    3005180920-2018-00987
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 12, 2018
    Report Date
    March 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: INNER SLEEVE OF THE PERCUTANEOUS TOWER HAS BEEN CUT USING COBB ELEVATOR AND PIN CUTTER DUE TO THE FACT THAT IT WAS NOT ABLE TO BE DISENGAGED FROM THE IMPLANT. CHECKING THE INSTRUMENT WE CAN DETECT THAT THE DEDICATED INSTRUMENT FOR THE RELEASE MANOEUVRE (03.52.10.0511, 513 AND 514) HAS NOT BEEN USED. IN THE SET ARE PRESENT 6 PIECES OF THE SAME REFERENCE INVOLVED. DURING THE VISUAL INSPECTION, IT WAS NOTICED THAT ONE OF THE LOT REPORTED IN THE EVENT NOTIFICATION WAS WRONG (PEDICLE SCREW PERCUTANEOUS TOWER ENH. REFERENCE 03.52.10.0521, LOT 1752415), AS THE RIGHT ONE IS MIS PEDICLE SCREW 03.52.10.0521 PERCUTANEOUS TOWER ENH. JPN LOT. 1850636. SO, THE BATCH REVIEW OF THIS LOT HAS BEEN PERFORMED ON 13 MARCH 2019: MIS PEDICLE SCREW 03.52.10.0521 PERCUTANEOUS TOWER ENH. JPN LOT 1850636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT WAS REPORTED, INVOLVING (B)(4) ITEMS OF THIS SAME LOT. SO, A TOTAL AMOUNT OF (B)(4) ITEMS HAVE BEEN INVOLVED IN THIS ISSUE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2018. LOT 1850307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM REFERENCE 03.52.325. LOT 1820458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 APRIL 2017. EXPIRATION DATE: 2023-04-05. 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. PEDICLE SCREW PERCUTANEOUS TOWER ENH. REFERENCE 03.52.10.0521. LOT 1752415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 FEBRUARY 2018. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. PRELIMINARY INVESTIGATION PERFORMED ON DECEMBER THE 12TH, 2018 BY R&D PRODUCT MANAGER: FROM THE DESCRIPTION OF THE EVENT AND FROM THE PICTURES ENCLOSED IT'S POSSIBLE TO STATE THAT THE INSTRUMENT WAS NOT USED IN THE CORRECT WAY. IN FACT, THE OUTER SLEEVE OF THE REFERENCE 03.52.10.0521 MUST NOT BE DISASSEMBLED FROM THE INNER SHAFT WHEN IT'S ENGAGED ON THE PEDICLE SCREW AND IT IS IMPORTANT TO USE THE MIS RELEASE SYSTEM, AS DESCRIBED BY THE SURGICAL TECHNIQUE, TO MINIMIZE POSSIBLE COMPLICATIONS AND/OR DAMAGE OF THE PERCUTANEOUS TOWERS. NOT APPROPRIATE INSTRUMENTS, COBB ELEVATOR AND PIN CUTTER, WERE USED TO DISASSEMBLE THE INNER SHAFT AND THIS CAUSE THE DEFORMATIONS OF THE INNER SHAFT, CLEARLY VISIBLE IN THE PICTURES. A DETAILED ANALYSIS CAN BE PERFORMED DURING THE VISUAL INSPECTION.

    Description of Event or Problem · 1

    DURING SURGERY PLIF, PERFORMED AT L5-S, IT WAS HARD TO ENGAGE THE SLEEVE WITH THE PEDICLE SCREW, SO FIRSTLY THE SURGEON CHANGED THE SLEEVE MULTIPLE TIMES. FINALLY THE SLEEVE WAS ABLE TO ENGAGE, BUT THE SURGEON FELT TOO TIGHT. IN THIS CASE, THE OUTER SLEEVE LOT1752415 AND THE INNER SLEEVE LOT1850307 WERE USED IN COMBINATION. THEN THE SURGEON WAS NOT ABLE TO DISENGAGE THE INNER SLEEVE FROM THE PEDICLE SCREW AT THE LEFT SIDE OF L5. HE DETACHED THE OUTER SLEEVE AND TRIED TO DISENGAGE AGAIN, BUT INNER SLEEVE DID NOT. AT THAT TIME THE OUTSIDE PINS DISENGAGED, BUT THE INSIDE PINS DID NOT. THE SURGEON TRIED TO ENLARGE THE INNER SLEEVE WITH THE COBB ELEVATOR, THEN TRIED TO BREAK THE INNER SLEEVE WITH THE PIN CUTTER, AFTER THAT TRIED TO HIT THE INSIDE OF THE INNER SLEEVE WITH THE COBB ELEVATOR AGAIN. FINALLY THE INNER SLEEVE WAS ABLE TO DISENGAGE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997575 PEDICLE SCREW PERCUTANOUS TOWER ENH. JPN SURGICAL INSTRUMENT FOR SPINE SURGERIES LXH MEDACTA INTERNATIONAL SA 1850307

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other