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

Model Number	THROMBINATOR¿ SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a sales representative via (b)(4) reported that an abs-10080 thrombonator had blood clotted in the device.The blood did not clot after 20 minutes of sitting in the syringe and did not clot when they withdrew it.At the end of the case, the blood ran completely unclotted when they poured it out while lifting the packaging.They stated they followed step-by-step protocol for whole nonanticoagulated blood and did not draw from an iv line.This was discovered during a procedure, with no reported patient harm.Additional information was received on 12/30/2024: the blood did not leak out of the abs-10080 thrombinator.The case was completed using tisseel (fibrin glue) from the facility's stock.The case was delayed twenty minutes to wait for the blood to clot.Then, there was additional time waiting for the tisseel to thaw.At the end of the case, the device was discarded, and all the blood was pulled but never clotted in the syringe.There were no reported adverse effects on the patient.This occurred in a procedure with anesthesia during a talar ocd using the thrombinator to top biocartilage on (b)(6)2004.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to user error due to improper insertion of the cassette.

• 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: 21168941
• Report Number: 1220246-2025-09490
• Device Sequence Number: 4251954
• Product Code: ORG
• UDI-Device Identifier: 00888867286580
• UDI-Public: (01)00888867286580(11)220503(17)270331(10)2099121000
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: BK241060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 2099121000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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