MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II REAMER, 6MM - HUDSON CONNECT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS II REAMER, 6MM - HUDSON CONNECT
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21/2021, it was reported by the sales representative via sems that ar-9202-02h univers ii reamer, 6mm - hudson connect, will not attached to the t handle.
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.One unpackaged ar-9202-02h, batch 04511733 was received for investigation.Visual inspection identified wear to the geometry of the connect feature at the proximal end of the reamer.The observed condition is consistent with the age of the device.

• Brand Name: UNIVERS II REAMER, 6MM - HUDSON CONNECT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19184641
• Report Number: 1220246-2024-02410
• Device Sequence Number: 7412959
• Product Code: LXH
• UDI-Device Identifier: 00888867058262
• UDI-Public: 00888867058262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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, 6MM - HUDSON CONNECT
• Device Catalogue Number: AR-9202-02H
• Device Lot Number: 04511733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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