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

Model Number	THROMBINATOR¿ SYSTEM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an autocart procedure no thrombin was produced.The mixture could not be produced because the thrombin could not be drawn from the filter.There was no harm for patient, operator or third party.The surgery was finished successfully by doing a pridie drilling.It was not necessary do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: THROMBINATOR¿ SYSTEM
• Common Device Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13472052
• Report Number: 1220246-2022-04425
• Device Sequence Number: 19913881
• Product Code: ORG
• UDI-Device Identifier: 00888867286580
• UDI-Public: 00888867286580
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK180299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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 Expiration Date: 05/31/2026
• Device Model Number: THROMBINATOR¿ SYSTEM
• Device Catalogue Number: ABS-10080
• Device Lot Number: 1161113099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/07/2022
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown