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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 16-mar-2026, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 quick connect handle snapped at the bottom when connected to the guide.This was discovered during a procedure with no patient harm.Additional information provided 23-mar-2026: it was further reported this was discovered during a tsa/eclipse total shoulder procedure that was completed with another quick connect handle.A one-minute delay was experienced and all pieces were retrieved from the patient.

• 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: 24816964
• Report Number: 1220246-2026-02063
• Device Sequence Number: 17649138
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: (01)00888867350021(11)210915(10)04512133
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 05/21/2026

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: 04512133
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown