MAUDE Adverse Event Report: ARTHREX, INC. QUICK CONNECT HANDLE, ASSEMBLY; ORTHOPEDIC MANUAL SURG INSTR

Model Number	QUICK CONNECT HANDLE, ASSEMBLY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/14/2025, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 quick connect handle broke while removing the glenoid targeter from over the guidewire.This occurred during use in a case with no patient effect.Procedure was completed successfully and the broken piece was retrieved.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed based on the picture attached, which shows the tip broken off of the device.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly excessive mechanical forces and/or prying/leveraging the device during use and extended use in the field.Manufacturing date 2021.

• Brand Name: QUICK CONNECT HANDLE, ASSEMBLY
• 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: 21771903
• Report Number: 1220246-2025-01212
• Device Sequence Number: 20882874
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: (01)00888867350021(11)211129(10)04512146
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/08/2025

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: QUICK CONNECT HANDLE, ASSEMBLY
• Device Catalogue Number: AR-9215-1-03
• Device Lot Number: 04512146
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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