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

Model Number	ECLIPSE & UNIVERS II RESECT GD S,RT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, the device is undamaged but a 2.9mm pin is stuck and protruding about 1 in from the proximal end of the ar-9401-11.The pin is bent and broken, and circumferential abrasion marks were found on the outer diameter.A likely cause of the event is prying/leveraging the pin during insertion.
Event or Problem Description
It was reported that the pin got stuck within the ar-9401-11 guide.The rep pried and pulled trying to remove the pin, but no avail.The surgeon finished the case by doing a free hand cut.

• Brand Name: ECLIPSE & UNIVERS II RESECT GD S,RT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12165218
• Report Number: 1220246-2021-03394
• Device Sequence Number: 3801249
• Product Code: MDM
• UDI-Device Identifier: 00888867060302
• UDI-Public: 00888867060302
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ECLIPSE & UNIVERS II RESECT GD S,RT
• Device Catalogue Number: AR-9401-11
• Device Lot Number: 250180606
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other