MAUDE Adverse Event Report: ARTHREX, INC. THROMBINATOR¿ SYSTEM; PLATELET AND PLASMA SEPARATOR

Model Number	THROMBINATOR¿ SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an autocart knee surgery the filter of the thrombinator¿ system broke.Per complaint reporter there was no harm for patient, operator or third party.The treatment was finished successfully with a new device with the same part number.It was not necessary to do a second treatment.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the two distal ends of the filter/female luercap assembly were broken off functional testing was not performed due to damage to the device.Per lt1-000286 thrombinator system number 11: connect the filter to the ¿withdraw¿ port.Invert the device at a 45° angle toward the ¿withdraw¿ port and withdraw serum through the filter.The most likely cause of failure was misaligned insertion or excessive force used when the devices were connected to the filter.

• Brand Name: THROMBINATOR¿ SYSTEM
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21632301
• Report Number: 1220246-2025-00996
• Device Sequence Number: 13093516
• Product Code: ORG
• UDI-Device Identifier: 00888867286580
• UDI-Public: (01)00888867286580(11)230701(17)280630(10)3159132364
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK241060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: THROMBINATOR¿ SYSTEM
• Device Catalogue Number: ABS-10080
• Device Lot Number: 3159132364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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
• Patient Sex: Unknown