MAUDE Adverse Event Report: ARTHREX, INC. AUTOLOGOUS TISSUE COLLECTOR; ARTHROSCOPIC ACCESSORIES

Model Number	AUTOLOGOUS TISSUE COLLECTOR
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided photo, which displays that the tissue collector top casing was separate from the tubing linked to the suction connector.However, without the return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.Refer to the complaint attached picture.
Event or Problem Description
It was reported that during an autocart procedure the tube loosened with light pull.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe (b)(6) 2023.It was confirmed that when the tube came off, the same nacl fluid used to collect the cartilage leaked out and in addition the collection container was opened, where cartilage could still be removed.Contamination in the sense of unwanted contact did not occur.

• Brand Name: AUTOLOGOUS TISSUE COLLECTOR
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 16973088
• Report Number: 1220246-2023-06774
• Device Sequence Number: 20476719
• Product Code: NBH
• UDI-Device Identifier: 00888867306189
• UDI-Public: 00888867306189
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 05/22/2023

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: AUTOLOGOUS TISSUE COLLECTOR
• Device Catalogue Number: ABS-1050
• Device Lot Number: 2284125995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/22/2023
• Date Device Manufactured: 11/01/2022
• 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