MAUDE Adverse Event Report: ARTHREX, INC. 10 MM SINGLE USE OATS SET; ORTHOPEDIC MANUAL SURG INSTR

Model Number	10 MM SINGLE USE OATS SET
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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
It was reported that during an oats osteochondral lesion procedure the inner part of the recipient harvester did not fit in the delivery tube, it was standing proud from the start.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully by improvising with a donor harvester.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-one unpackaged ar-1981-10s, oats® set, batch 4211151341, was received for investigation.Visual inspection of the device noted that it has sustained surface damage along the body.Functional testing confirmed that the device could be assembled as intended.The graft delivery tube properly fit into the shaft at the specified depth, and no issues were observed with its fit.No problem found.-refer to investigation photos.Complaint allegation is not confirmed.

• Brand Name: 10 MM SINGLE USE OATS SET
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22665593
• Report Number: 1220246-2025-03148
• Device Sequence Number: 18044266
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: (01)00888867025356(11)240901(17)290831(10)4211151341
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 10/15/2025

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: 10 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-10S
• Device Lot Number: 4211151341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown