MAUDE Adverse Event Report: TEKNIMED SAS MINI-MALAX ADAPTED TO HIGH VISCOSITY INJECTION SYSTEM; ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

Model Number	T060420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: MINI-MALAX ADAPTED TO HIGH VISCOSITY INJECTION SYSTEM
• Common Device Name: ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS
• Manufacturer (Section D): TEKNIMED SAS; 8 rue du corps franc pommiès; vic-en-bigorre, 65500 ; FR 65500
• Manufacturer Contact: 8 rue du corps franc pommiès; vic-en-bigorre, 65500
• MDR Report Key: 25223253
• Report Number: 3003854593-2026-00001
• Device Sequence Number: 15905203
• Product Code: JDZ
• UDI-Device Identifier: 03760177043138
• UDI-Public: 03760177043138
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: T060420
• Device Lot Number: 060426034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male