MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR; MANUAL INSTR, GENERAL SURGICAL

Model Number	ECLIPSE HUMERAL HEAD EXTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a facility representative via sems that a ar-9401-17 eclipse is broken.This was discovered in a case.There was no patient effect reported.No additional information provided.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 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 results of the investigation of this complaint did not change the harm identified during intake.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.

• Brand Name: ECLIPSE HUMERAL HEAD EXTRACTOR
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19319432
• Report Number: 1220246-2024-03303
• Device Sequence Number: 7592071
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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 HUMERAL HEAD EXTRACTOR
• Device Catalogue Number: AR-9401-17
• Device Lot Number: 250151104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown