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

Model Number	NEEDLE, TUOHY WITH OBTURATOR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that, during an autocart procedure, metal debris was found in the harvested cartilage mass.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.09-oct-2023 update dw: further information was provided that after the cartilage is cut with the sabre ar-7300sr and collected with the graftnet it was noticed that no metal particles were found in the cartilage mass at this moment.The metal abrasion only became visible in the joint when the cartilage mass was applied, indicating that the debris was caused by the syringe.The surgeon decided to use the mass with the particles to finish the surgery successfully.
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 excessive pressure used when drawing back the syringe and/or excessive friction during use.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18001813
• Report Number: 1220246-2023-08348
• Device Sequence Number: 15116075
• Product Code: NBH
• UDI-Device Identifier: 00888867001817
• UDI-Public: 00888867001817
• 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,Followup
• Report Date (Section B): 03/10/2025

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: NEEDLE, TUOHY WITH OBTURATOR
• Device Catalogue Number: ABS-1001
• Device Lot Number: 3061129650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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