MAUDE Adverse Event Report: ARTHREX, INC. PIN SET, UNIVERS II/ ECLIPSE; MANUAL INSTR, GENERAL SURGICAL

Model Number	PIN SET, UNIVERS II/ ECLIPSE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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, the ar-9401-13 was returned with a pin c4481 stuck inside.The pin met specifications of drawing c4481 rev.5.Note that the tolerance of the upper end of the pin diameter was decreased from ±.005 to +.001/-.005 in a subsequent revision.The devices met specifications.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.
Event or Problem Description
It was reported that the pin from ar-9207s kit (lot:11536563) was introduced into the ar-9401-13 cut guide.Pin bound up in cannulation causing guide to spin and breaking off two ar-9202 version rods.Pin was not able to be removed from guide.

• Brand Name: PIN SET, UNIVERS II/ ECLIPSE
• 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: 19563524
• Report Number: 1220246-2024-06022
• Device Sequence Number: 7606520
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• 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): 06/18/2024

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: PIN SET, UNIVERS II/ ECLIPSE
• Device Catalogue Number: AR-9207S
• Device Lot Number: 11536563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown