BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-MALAX ADAPTED TO HIGH VISCOSITY INJECTION SYSTEM

    MDR report key: 25223253 · Received May 19, 2026

    Report

    Report Number
    3003854593-2026-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    TEKNIMED SAS
    Product Code
    JDZ
    UDI-DI
    03760177043138
    PMA / PMN Number
    K161114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE IS NOT YET AVAILABLE FOR INVESTIGATION, THE TEAM HAS STARTED WORKING ON THE PRELIMINARY INVESTIGATIONS RELATED TO THIS MDR. SEE BELOW FINDINGS AS PER CURRENT STATE: - SALES REVIEW: OVER THE TOTAL OF (B)(4) UNITS OF KITS SHIPPED WORLDWIDE COMPOSED OF THE AFFECTED MINI-MALAX BATCH 060426034, NO OTHER FEEDBACK OR COMPLAINT RELATED TO DETACHMENT OF THE BLADE HAVE BEEN REPORTED. THE SALE HISTORY FOR THIS BATCH IS THEREFORE CONSIDERED COMPLAINT. - BATCH REVIEW: A REVIEW OF THE CEMENT BATCH RECORD 043A25243 WAS PERFORMED. ALL RESULTS OBTAINED WERE IN COMPLIANCE WITH SPECIFICATIONS. THE CONFORMITY OF THE CEMENT THEREFORE IS NOT IN QUESTION. - CASE REVIEW: THE DISTRIBUTOR SPECIFIED THAT THE MIXER BASE WAS CORRECTLY SECURED IN THE HIGH POSITION, AS INDICATED IN THE INSTRUCTIONS FOR USE, IN ORDER TO PREVENT BLADE DETACHMENT.

    Description of Event or Problem · 0

    AT THE START OF THE MIXING PROCESS, THE BLADE DETACHED FROM THE MIXER LID. AFTER ATTEMPTING TO REPOSITION IT, IT DID NOT ROTATE PROPERLY AND PRODUCED A GRINDING NOISE. AS A RESULT, THE CEMENT WAS NOT MIXED CORRECTLY AND THE REACTION PROCESS WAS COMPROMISED. ALTHOUGH THE PRE-DEFINED STORAGE CONDITIONS, PREPARATION STEPS, AND TIMING WERE FOLLOWED, THE CEMENT BEGAN TO HARDEN VERY RAPIDLY APPROXIMATELY 3 MINUTES AFTER MIXING THE LIQUID AND POWDER. NO PHYSICAL INJURY OCCURRED, HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED. THE CEMENT COULD NO LONGER BE INJECTED. A SMALL AMOUNT HAD ALREADY BEEN DELIVERED INTO THE TRAJECTORY, BUT THE INJECTORS BECAME BLOCKED AND CLOGGED WITHIN MINUTES. NO ADDITIONAL CEMENT OR INJECTORS COULD BE INTRODUCED, LEADING THE SURGEON TO END THE PROCEDURE, AS THE TREATMENT COULD NOT BE PROPERLY COMPLETED. AT THIS TIME, NO INFORMATION WERE OBTAINED REGARDING ADDITIONAL PROCEDURES FOR THE PATIENT OR ANY FURTHER TREATMENT DECISIONS MADE BY THE SURGEON. A MAXIMUM VOLUME OF 1 / 1.5 CC OF CEMENT, CERTAINLY FAR LESS THAN 2 CC, WAS INJECTED INTO AN L2. NO LEAKS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343692 MINI-MALAX ADAPTED TO HIGH VISCOSITY INJECTION SYSTEM ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS JDZ TEKNIMED SAS T060420 060426034 03760177043138

    Patients

    Seq Age Sex Outcome Treatment
    1