MAUDE Adverse Event Report: ARTHREX, INC. SMALL JOINT OATS SET, 6 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	SMALL JOINT OATS SET, 6 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that the donor t-handle from an ar-1981-06s single use osteochondral autograft transfer system oats set autograft diameter 6 mm metal began to warp after it was inserted, and at the desired depth.The surgeon was able to remove the donor t-handle without breaking it.An ar-8981-06s small joint oats, donor t-handle was opened and used.The same thing happened; it warped, but during removal, it broke in the condyle.Then, the surgeon attempted to use an ar-1981-08s, oats size 8mm, and an ar-1981-10s oats, size 10 mm, but it would not harvest a plug.After an extended period of time, the surgeon was able to remove the broken metal with a clamp.The surgeon was able to use the plug out of the broken piece and completed the case successfully.This was discovered during an autograft oats transfer procedure.Additional information received on 4/18/2023: the case was delayed about forty-five minutes to an hour, and additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image submitted for evaluation from the field, it is evident that the device was cracked intraoperatively.Since the device was not returned for evaluation, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: SMALL JOINT OATS SET, 6 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: vik bajnath ; 8009337001
• MDR Report Key: 16914428
• Report Number: 1220246-2023-06722
• Device Sequence Number: 16684751
• Product Code: MDM
• UDI-Device Identifier: 00888867056817
• UDI-Public: 00888867056817
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SMALL JOINT OATS SET, 6 MM
• Device Catalogue Number: AR-8981-06S
• Device Lot Number: 3018128395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown