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

Model Number	10 MM SINGLE USE OATS SET
Health Effect - Clinical Codes	Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that patient underwent an allograft oats transfer to the patella procedure on (b)(6) 2022.An ar-1981-10s osteochondral autograft transfer system oats was used to complete the procedure.During the procedure, a harvester was used to extract a plug from the patella.The patient's bone was too hard, and the plug did not come out with the harvester.A reamer was then used to ream out the recipient site.It was this time that the harvester broke off and fell into the wound during the attempted plug extraction.However, this remained unknown until the patient went for a two week follow up visit and an x-ray showed a metal in the patient's joint.On (b)(6) 2022, patient had a revision procedure and had the broken tip removed.
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.

• Brand Name: 10 MM SINGLE USE OATS SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16051630
• Report Number: 1220246-2022-05982
• Device Sequence Number: 17743320
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 12/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-10S
• Device Lot Number: 2066120104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/27/2022
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown