MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ M/46.0MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ECLIPSE RESECT PROTECTOR,SZ M/46.0MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
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.Complaint is confirmed.Upon visual evaluation, oxidation/discoloration was observed on both sides of the device.The most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
It was reported on 03/03/2023 by a sales representative via sems that an ar-9221ag drill is bent, ar-9628 tip is broken, and ar-9401-40, ar-9401-46, ar-9401-50 resect protector are rusty.Case involvement, no patient effect.

• Brand Name: ECLIPSE RESECT PROTECTOR,SZ M/46.0MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19382491
• Report Number: 1220246-2024-03739
• Device Sequence Number: 6415130
• Product Code: LXH
• UDI-Device Identifier: 00888867060371
• UDI-Public: 00888867060371
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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 Model Number: ECLIPSE RESECT PROTECTOR,SZ M/46.0MM
• Device Catalogue Number: AR-9401-46
• Device Lot Number: 051838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown