MAUDE Adverse Event Report: ARTHREX, INC. 12MM SINGLE USE OATS DISPOSABLE KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	12MM SINGLE USE OATS DISPOSABLE KIT
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 09/03/2024, it was reported by a sales representative via (b)(4) that (qty.2) of an abs-8981-12s oats 2.0 single-use set was received with a dull tip on the handle and not sharp, and the internal plunge was stuck/too tight.Then, another abs-8981-12s oats 2.0 single-use set from the same lot was opened, and the same issue occurred.The case was completed successfully using force and a bigger mallet to mallet the disposable to downsize the allograft.When force was applied through the graft, they were concerned that the graft would break or the device would go through.There was no impact on the patient.This was discovered during an oat procedure on the elbow procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
The complaint allegation was confirmed.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 reported failure has been attributed to an issue with the supplier manufacturing process.For details, refer to ncr-27165.

• Brand Name: 12MM SINGLE USE OATS DISPOSABLE KIT
• 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: 20238218
• Report Number: 1220246-2024-07681
• Device Sequence Number: 15464488
• Product Code: LXH
• UDI-Device Identifier: 00888867343894
• UDI-Public: 00888867343894
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 12MM SINGLE USE OATS DISPOSABLE KIT
• Device Catalogue Number: ABS-8981-12S
• Device Lot Number: 4057139050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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