MAUDE Adverse Event Report: ARTHREX, INC. 8 MM SINGLE USE OATS SET; ORTHOPEDIC MANUAL SURG INSTR

Model Number	8 MM SINGLE USE OATS SET
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 3rd sep 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1981-08s, single use osteochondral autograft transfer system oats® set autograft diameter 8 mm, the surgeon found that the edge of the blade was frayed (refer to attached images).The fragments broke off inside patient and the fragments were retrieved from the patient.This was detected during an arthroscopic-assisted left ankle talus cartilage transplantation surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1981-08s.There were no patient harm and no secondary surgery needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1981-08s single use osteochondral autograft transfer system oats® set autograft diameter 8 mm batch 4060139202 was received for evaluation.Only the white handle oat was received.Visual inspection revealed that the blades' cutting edge at the tip was damaged, with visible dents, nicks, and missing or broken fragments.The most likely cause of the reported and observed failure was user error, including excessive mechanical stress during use.Direction for use dfu-0070-eor1_fmt_en.Osteochondral autograft transfer system (oats®), coring reamer and bone graft harvester.E.Warnings.3.Oats only: autograft transplantation requires careful harvesting, precise sizing, and accurate placement of osteochondral autograft cylinders (grafts) with hyaline cartilage from a donor joint to a recipient joint.4.Oats only: when inserting the osteochondral graft (donor) into the osteochondral socket (recipient), do not countersink the hyaline cartilage graft.

• Brand Name: 8 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: 23095079
• Report Number: 1220246-2025-03952
• Device Sequence Number: 8765741
• Product Code: LXH
• UDI-Device Identifier: 00888867025332
• UDI-Public: (01)00888867025332(11)240418(17)290331(10)4060139202
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/17/2025

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: 8 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-08S
• Device Lot Number: 4060139202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown