MAUDE Adverse Event Report: ARTHREX, INC. SMALL JOINT OATS SET, 8 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	SMALL JOINT OATS SET, 8 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04 november 2025, it was reported by a sales representative via email that an ar-8981-08s, small joint oats set 8 mm was reported to be stuck during use.This occurred on (b)(6) 2025 during an acl stage 1 grafting of previous acl tunnel.It was reported that while using 8mm oats kit, the screw tap would not eject the bone dowel.The case was completed successfully using another kit and this worked correctly.There was case involvement.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.The images show no external fractures, bending, or deformation of the handle, metal interface, or donor shaft.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 of the reported failure can be attributed to a mishandling of the device, which may have led to internal obstruction, residual biological material, or mechanical jamming within the donor shaft.Without physical device return and internal examination, the case cannot be confirmed.

• Brand Name: SMALL JOINT OATS SET, 8 MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23630489
• Report Number: 1220246-2025-05153
• Device Sequence Number: 13340899
• Product Code: MDM
• UDI-Device Identifier: 00888867056824
• UDI-Public: (01)00888867056824(11)240627(17)290531(10)4149141656
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/16/2026

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: SMALL JOINT OATS SET, 8 MM
• Device Catalogue Number: AR-8981-08S
• Device Lot Number: 4149141656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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