MAUDE Adverse Event Report: ARTHREX, INC. INSTR CS,ECLIPSE ARTHROPLASTY SYS; MANUAL INSTR, GENERAL SURGICAL

Model Number	INSTR CS,ECLIPSE ARTHROPLASTY SYS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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.Complaint confirmed.Two ar-9400c4 sets (no batch/sn indicators present) were received for investigation.Visual inspection identified scuff markings across the outer coating of the sets that were consistent with wear and tear damage, as well as peeling of the coating within the trays.This is most likely the result of repeated cleaning cycles, and it is unknown how many cleaning cycles the trays have been subjected to.
Event or Problem Description
It was reported that the following sets are chipped and need to be replaced; ar-9217c; ar-9400c4; ar-9225c; ar-9226abc; ar-9226ubc; ar-9226cc; ar-9501-hc2; ar-9501-hc1; ar-9615c-1; ar-9615c-2.

• Brand Name: INSTR CS,ECLIPSE ARTHROPLASTY SYS
• 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: 19535646
• Report Number: 1220246-2024-05763
• Device Sequence Number: 17748561
• Product Code: MDM
• UDI-Device Identifier: 00888867139602
• UDI-Public: 00888867139602
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: INSTR CS,ECLIPSE ARTHROPLASTY SYS
• Device Catalogue Number: AR-9400C4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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