MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II REAMER, 8MM - HUDSON CONNECT; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS II REAMER, 8MM - HUDSON CONNECT
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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.The complaint is not confirmed.One unpackaged ar-9202-28h serial/batch number04512137 was received for investigation.Functional testing with a matting part t-handle ar-9202-15h, batch 8001602, found that the device attached to the handle without issues.Upon visual evaluation, scratches on the hudson adapter and nicks on the cutting blades were noted.No problem found.
Event or Problem Description
On 4/5/2023, it was reported by a sales representative via sems that an ar-9202-28h univers ii reamer had an issue.This canal reamer "device" was attached to a reamer "t-handle" in a normal manner and would not lock onto the t handle.A second t handle was used and it would not lock onto the device as well.The next size larger calar reamer was used to complete the surgical procedure in a standard fashion.No added time or adverse event occurred.This occurred during use with no patient harm.Additional information has been requested.On 4/7/2023, the sales representative provided the following information via email: this occurred during a reverse tsa procedure on (b)(6) 2023.No piece of the instrument broke while it was not locking.The bone quality of the patient was not provided.

• Brand Name: UNIVERS II REAMER, 8MM - HUDSON CONNECT
• 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: 19373898
• Report Number: 1220246-2024-03672
• Device Sequence Number: 7703319
• Product Code: MDM
• UDI-Device Identifier: 00888867058460
• UDI-Public: 00888867058460
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: UNIVERS II REAMER, 8MM - HUDSON CONNECT
• Device Catalogue Number: AR-9202-28H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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