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

Model Number AUTOLOGOUS TISSUE COLLECTOR

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 315761475
• Report Number: 1220246-2023-06774
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867306189
• UDI-Public: 00888867306189
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUTOLOGOUS TISSUE COLLECTOR
• Device Catalogue Number: ABS-1050
• Device Lot Number: 2284125995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1