MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ L/50.0MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ECLIPSE RESECT PROTECTOR,SZ L/50.0MM
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an ar-9401-17 humeral head extractor tip was chipped, and an ar-9401-50 resection protector was rusted.This was discovered before use in a case upon opening the tray and was not used.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-9401-50 batch 051838 was received for evaluation.Upon visual evaluation, it was noted that the instrument has many discoloration spots and rust/corrosion.Nicks were observed on the edges.The most likely cause of the reportable failure could be using the incorrect cleaning process.Per dfu-0023-7 at revision 0.F.Cleaning.Caution: low acid or high alkaline solutions are not recommended, as they corrode metal parts and anodized aluminum and compromise polymer plastics, such as fep (fluorinate dethylenepropylene), abs (acrylonitrile butadiene styrene), ultem¿, lexan¿, and cycolac¿.If non-neutral ph cleaning chemistries are utilized, care should be taken to ensure appropriate rinsing, as validated by the end-user facility, and neutralization steps are taken so as to not negatively impact the fit, finish, or function of the device.Cleaning solutions should always be mixed to the manufacturer¿s specification for concentration, and cleaning should be conducted at ambient temperature unless otherwise stated in the cleaning solution manufacturer¿s instructions.

• Brand Name: ECLIPSE RESECT PROTECTOR,SZ L/50.0MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18258012
• Report Number: 1220246-2023-09133
• Device Sequence Number: 17119870
• Product Code: LXH
• UDI-Device Identifier: 00888867060388
• UDI-Public: 00888867060388
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 11/19/2024

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 L/50.0MM
• Device Catalogue Number: AR-9401-50
• Device Lot Number: 051838
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2018
• 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