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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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 07/31/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8981-08s small joint oats set when trying to harvest the donor side with a harvester, it didn't work, even though following the instructions in the manual.There is no specific issue reported.The complaint was that the sample was not extracted properly even though it was used according to the instructions.A new one was opened and was able to harvest it cleanly.The process was completed without any problems and no patient harms.This occurred during use in a case with no patient effect.
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 for the reported failure can be attributed to user error.

• 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: 22842277
• Report Number: 1220246-2025-03534
• Device Sequence Number: 4926775
• Product Code: MDM
• UDI-Device Identifier: 00888867056824
• UDI-Public: 00888867056824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/12/2025

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: SMALL JOINT OATS SET, 8 MM
• Device Catalogue Number: AR-8981-08S
• Device Lot Number: 421151696
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown