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	02/01/2021
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.It was reported that the pin was cold welded to the guide.Visual evaluation identified that the guide was not returned with the pin and, therefore, the complaint is unconfirmed as the devices were found not to be cold welded together.Additionally, unrelated to the reported event, circumferential damage was found throughout the pin (images 1-2).The root cause of the circumferential damage is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon mating the pin with the guide.The reported event is unconfirmed based upon investigation of the returned product.
Event or Problem Description
It was reported during a procedure, the 2.8mm pin within ar-9207s became cold welded into resection guide ar-9401-13.It was replaced and the case was completed with no further issues.See photo attached.

• 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: 19134670
• Report Number: 1220246-2024-02127
• Device Sequence Number: 4658209
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• 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
• Report Date (Section B): 04/18/2024

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 Expiration Date: 07/31/2025
• 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: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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