MAUDE Adverse Event Report: ARTHREX, INC. NEEDLE, TUOHY WITH OBTURATOR; ARTHROSCOPIC ACCESSORIES

Model Number	NEEDLE, TUOHY WITH OBTURATOR
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an auto cart (minced cartilage) knee surgery it was noticed that foreign material is present in the collected cartilage material after it has been introduced into the insertion sleeve (needle, tuohy).Per complaint reporter there was no harm for patient, operator or third party.No further information received.With case (b)(4) information was provided that the same error occurred previously with no further information available, therefore this case was created.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: NEEDLE, TUOHY WITH OBTURATOR
• 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: jared engle ; 8009337001
• MDR Report Key: 24567679
• Report Number: 1220246-2026-01345
• Device Sequence Number: 13163319
• Product Code: NBH
• UDI-Device Identifier: 00888867001817
• UDI-Public: 00888867001817
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: NEEDLE, TUOHY WITH OBTURATOR
• Device Catalogue Number: ABS-1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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