MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE & UNIVERS II RESECT GD S,LFT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	ECLIPSE & UNIVERS II RESECT GD S,LFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2021, it was reported by a facility representative via sems that an ar-9401-10 eclipse universe the pin and version became stuck in the guide causing the version rod to break.This was discovered during use in a shoulder arthroplasty on (b)(6) 2021. the case was completed by free hand cut.
Additional Manufacturer Narrative
Complaint confirmed, the ar-9401-10 received was returned with an unidentified pin stuck and protruding from the proximal end.The pin was determined to be c4481-01 from ar-9207s.The pin was found to meet specifications.

• Brand Name: ECLIPSE & UNIVERS II RESECT GD S,LFT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12435082
• Report Number: 1220246-2021-03611
• Device Sequence Number: 4739485
• Product Code: MDM
• UDI-Device Identifier: 00888867060296
• UDI-Public: 00888867060296
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/01/2021

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 & UNIVERS II RESECT GD S,LFT
• Device Catalogue Number: AR-9401-10
• Device Lot Number: 250194907
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1