BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOCKER

    MDR report key: 11345721 · Received February 18, 2021

    Report

    Report Number
    3003853072-2021-00006
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    July 6, 2020
    Report Date
    February 18, 2021
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    UDI-DI
    0370046000155
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED IN THE US, BUT IS SIMILAR TO K111301. DEVICE EVALUATION: VISUAL INVESTIGATION REVEALS THAT THE INNER HEXES ON FOUR OF THE BLOCKERS WERE STRIPPED. FUNCTIONAL INVESTIGATION USING MATING PARTS SHOWED THAT THE BLOCKERS WITH DAMAGED THREADS WERE NON-FUNCTIONAL BECAUSE THEY COULD NOT FULLY ENGAGE THE BLOCKER HOLDER. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING TIGHTENING. DHR REVIEW AND RELATED ACTIONS: PER THE DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3003853072-2021-00005 THRU 3003853072-2021-00008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEX ON FIVE BLOCKERS WERE STRIPPED DURING INSTALLATION WITHIN SURGERY. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THAT THE THREADS ON FOUR OF THE BLOCKERS WERE STRIPPED. THE BLOCKERS WERE REMOVED AND REPLACED DURING THE SURGERY WITHOUT PATIENT IMPACT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239219 BLOCKER SIMILAR TO INSTINCT JAVA SYSTEM NKB ZIMMER SPINE N/A E84612 0370046000155

    Patients

    Seq Age Sex Outcome Treatment
    1