MAUDE Adverse Event Report: ARTHREX, INC. END CUTTER, 3.8MM X 13CM; SAW BLADE

Model Number	END CUTTER, 3.8MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is not confirmed.One unpackaged ar-8380ec was received for investigation.Visual inspection concluded without the observance of any breakage across the device.No problem found.
Event or Problem Description
(b)(6) 2021, it was reported by a distributor via sems that an ar-8380ec end cutter head of the blade fell apart.This was discovered during a arthroscopy meniscectomy procedure on (b)(4) 2021.Surgeon switched devices and was able to complete case without further issues.

• Brand Name: END CUTTER, 3.8MM X 13CM
• Common Device Name: SAW BLADE
• 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: 19457395
• Report Number: 1220246-2024-04809
• Device Sequence Number: 15156529
• Product Code: GFA
• UDI-Device Identifier: 00888867043374
• UDI-Public: 00888867043374
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Expiration Date: 04/30/2024
• Device Model Number: END CUTTER, 3.8MM X 13CM
• Device Catalogue Number: AR-8380EC
• Device Lot Number: 10316440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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