BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)

    MDR report key: 7662373 · Received July 4, 2018

    Report

    Report Number
    3005180920-2018-00481
    Event Type
    Malfunction
    Date Received
    July 4, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834295
    PMA / PMN Number
    K121115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE LOT OF THE BROKEN SCREW IS UNKNOWN IT IS REPORTED IN THE MDR ALL THE POSSIBLE LOT INVOLVED. LOT 165548: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2016. EXPIRATION DATE: 06.11.2021. 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. REFERENCE 03.50.031 (K121115) PEDICLE SCREW 7X45: LOT 1721021: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 FEBRUARY 2018. EXPIRATION DATE:2023-02-06. 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. REFERENCE 03.50.030 (K121115) PEDICLE SCREW 7X40: LOT 1721195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2018. EXPIRATION DATE: 2023-01-03. 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. REFERENCE 03.50.061 (K132878) PEDICLE SCREW 8X75MM LOT 152328: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 MAY 2015. EXPIRATION DATE: 2020-04-22 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. VISUAL INSPECTION PERFORMED ON 27TH OF JUNE, 2018. A SMALL PIECE OF THE SETSCREW (THE FIRST THREAD) DETACHED FROM THE SETSCREW. POTENTIAL CROSS THREADING OF THE SETSCREW (WRONG ENGAGEMENT OF THE THREAD) MIGHT HAVE RESULTED IN DAMAGE OF THE SETSCREW DURING FINAL TIGHTENING. CROSS THREADING IS A RARE EVENT THAT CAN OCCUR WITH EVERY PEDICLE SCREW SYSTEM. INSTRUMENTS ARE PROVIDED IN THE SET TO ENSURE THE CORRECT ALIGNMENT AND ENGAGEMENT OF THE SETSCREW (E.G. ENH. SETSCREWDRIVER 03.51.10.0128; ONE STEP REDUCER 03.51.10.0181; COUNTERTORQUE 03.51.10.0064). THE SURGEON IS USUALLY ABLE TO NOTICE IF CROSS THREADING OCCURRED BY A SIGNIFICANT FRICTION/TIGTHENING FORCE, AND IN SUCH CASE HE CAN REMOVE AND REPOSITION THE SETSCREW IN THE PEDICLE SCREW. EVEN IN CASE OF CROSS THREADING, DAMAGE TO THE SETSCREW AND/OR TO THE PEDICLE SCREW HEAD IS VERY UNLIKELY. INTERNAL TESTS HAVE BEEN PERFORMED TO REPRODUCE SUCH EVENT (CROSS THREADING+FINAL TIGHTENING) AND IN NO CASE A BREAKAGE OF THE SETSCREW SIMILAR TO THE PICTURES REPORTED WITH THIS COMPLAINT OCCURRED. EVENTS OF THREAD BREACKAGE AS PRESENTED IN THE COMPLAINT, MIGHT BE ALTERNATIVELY RELATED TO A DIFFERENT MANOEUVRES, SUCH AS HAMMERING OF THE SETSCREW AGAINST THE TULIP.

    Description of Event or Problem · 1

    SET SCREW (SPECIFIC LOT UNKNOWN) HAS BEEN BROKEN DURING TIGHTENING, SMALL PIECES REMAINED IN THE PATIENT'S WOUND. THE SET SCREW WAS REPLACED WITH A NEW ONE.WHEN THE SURGEON TIGHTENED THE SET SCREW AFTER IMPLANTATION OF THE PEDICLE SCREW 7X40 AT L5, HE DISCOVERED THE SET SCREW WAS BROKEN. HE REMOVED THE BROKEN PIECE OF THE SET SCREW, BUT SMALL PIECES (2 MM) REMAINED IN THE PATIENT BODY. THE SET SCREW WAS REPLACED WITH A NEW ONE, THE SURGEON DECIDED TO NOT RETRIEVE THE SMALL PIECES THAT REMAINED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503984 PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS) PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 165548 07630030834295

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other