BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUST ROD TI 5.5X480

    MDR report key: 6604404 · Received June 1, 2017

    Report

    Report Number
    3005180920-2017-00270
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 2, 2017
    Report Date
    July 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    PMA / PMN Number
    K121115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 29 MAY 2017. LOT 141222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2015. EXPIRATION DATE: 2020-05-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MUST ROD TI 5.5X480, CODE 03.50.403, LOT. 1520147 (K121115), 2 ITEMS OF THE SAME LOT INVOLVED. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2016. EXPIRATION DATE: 2021-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THREE SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. MUST ROD TI 5.5X300, CODE 03.50.402, LOT. 144734 (K121115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 31 MAY 2017 THE CLEANING AND PACKAGING MANGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: CONSIDERING THE ROD DESIGN AND LENGTH, IF IT IS NOT CAREFULLY MANAGED, IT CAN BE INVOLVED IN PACKAGING BREAKAGE. THE MOST PROBABLE ROOT CAUSE IS DUE TO THE INTERACTION OF THE FOLLOWING FACTORS: - THE MATERIAL OF THE POUCH, OPA/PE, - THE FOLDING OF THE POUCH, - LOT SPECIFIC HANDLING DAMAGE DURING PACKAGING AND/OR STERILIZATION. SPECIFICALLY, IT IS POSSIBLE THAT THERE WAS LOT SPECIFIC DAMAGE DURING THE PACKAGING PRODUCTION PROCESS AND/OR STERILIZATION PROCESS, AS THE PACKAGING CONFIGURATION (OPA/PE POUCHES AND POUCH FOLDING) HAS BEEN VALIDATED FOR SHIPPING UNDER NORMAL OPERATING CONDITIONS. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 21 JUNE 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE PACKAGING IS COMPROMISED, THE ROD PERFORATED THE PEEL POUCH PROBABLY DURING TRANSPORTATION, HANDLING OR STORAGE. CONSIDERING THE ROD DESIGN AND LENGTH, IF IT IS NOT CAREFULLY MANAGED CAN INVOLVED IN PACKAGING BREAKAGE. THE MOST PROBABLE ROOT CAUSE IS DUE TO THE INTERACTION OF THE FOLLOWING FACTORS: THE MATERIAL OF THE POUCH, OPA/PE, THE FOLDING OF THE POUCH, LOT SPECIFIC HANDLING DAMAGE DURING PACKAGING AND/OR STERILIZATION. SPECIFICALLY, IT IS POSSIBLE THAT THERE WAS LOT SPECIFIC DAMAGE DURING THE PACKAGING PRODUCTION PROCESS AND/OR STERILIZATION PROCESS, AS THE PACKAGING CONFIGURATION (FULL WEIGHT OF PRODUCT, WITH OPA/PE POUCHES, AND POUCH FOLDING) HAS BEEN VALIDATED FOR SHIPPING UNDER NORMAL OPERATING CONDITIONS.

    Description of Event or Problem · 1

    PACKAGING MATTER. BOTH THE PACKAGES WERE FOUND BROKEN (INNER AND OUTER ONE). SIX RODS IN TOTAL NEEDED TO BE OPEN TO USE 2 RODS. THE PROPER SIZE WOULD BE TO OPEN A 300MM ROD. THE FIRST ONE IMPLANTED WAS FINE. THE SECOND ONE AVAILABLE WAS FOUND WITH A DAMAGED PACKAGING. THE SURGEON HAD TO OPEN THE 480MM RODS, BUT UNFORTUNATELY 3 OF THEM (ON A TOTAL OF 4 RODS AVAILABLE) WERE DAMAGED IN THE PACKAGING. THE SURGEON WAS ABLE TO FINISH THE SURGERY, BUT WITH NO MORE RODS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385310 MUST ROD TI 5.5X480 SPINAL ROD KWP MEDACTA INTERNATIONAL SA 141222

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other