MAUDE Adverse Event Report: ARTHROSURFACE NANOFX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	FURS-0100
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Abrasion (1689); Foreign Body In Patient (2687)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by arthrosurface or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 it was reported to anika that during an ankle procedure on a patient of unknown age and demographic, the surgeon was going to mallet the needle into the patient's bone off axis.The device slipped resulting in cartilage damage.The surgeon reported what appeared to be a metallic flake in the patient's joint space.The flake was reportedly cleaned out.The surgeon stopped using the device.There was no report of a device deficiency.There was no report of any negative patient or user impact.There was no report of a delay in the procedures.The current status of the patient is unknown.This is one of two reports being submitted for each component used during the procedure.Additional information was solicited.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event was not confirmed.The cause of the reported event could not be established based on the insufficient information that was provided.Additional information was not provided upon request.The batch record, material certifications and process certifications were reviewed.There was no nonconformances related to the reported event documented in the manufacturing record.The lot was manufactured and released to applicable procedures and specifications.A three year retrospective review of all nonconformances was performed for the reported product.There was no nonconformances associated with the reported event.A supplemental report will be submitted upon receipt of new and relevant information.The reported event will continue to be monitored and trended for future analysis.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by arthrosurface or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 it was reported to anika that during an ankle procedure on a patient of unknown age and demographic, the surgeon was going to mallet the needle into the patient's bone off axis.The device slipped resulting in cartilage damage.The surgeon reported what appeared to be a metallic flake in the patient's joint space.The flake was reportedly cleaned out.The surgeon stopped using the device.There was no report of a device deficiency.There was no report of any negative patient or user impact.There was no report of a delay in the procedures.The current status of the patient is unknown.This is one of two reports being submitted for each component used during the procedure.Additional information was solicited.

• Brand Name: NANOFX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 20146388
• Report Number: 3004154314-2024-00019
• Device Sequence Number: 17202758
• Product Code: LXH
• UDI-Device Identifier: M528FURS01000
• UDI-Public: M528FURS01000
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Catalogue Number: FURS-0100
• Device Lot Number: 75HA6497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown