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	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
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
It was reported that during an oats surgery while the surgeon inserted the device the cutting edge became bent and broke.The broken pieces were retrieved out of the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint is confirmed.Upon visual evaluations of the pictures attached to the complaint of an ar-1981-10s -10mm, single-use oats set.It is concluded that the c2787-recipient harvester single-use oats show damage, with cracks and burrs at the device's cutting tip.The cause remains undetermined.

• 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: 16361759
• Report Number: 1220246-2023-06269
• Device Sequence Number: 12610175
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 2097120950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown