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	12/26/2024
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 12/30/2024, a sales representative reported via sems-(b)(4) that an ar-9236-03pp univers vaultlock¿ glenoid trial, ar-9231-vl-03 univers vaultlock glenoid drill guide, and ar-9215-1-03 universal quick connect handle broke.No further information was provided.This was discovered during use, with no reported patient harm.Additional information was received on 01/07/2024: this was discovered during an anatomic total shoulder arthroplasty procedure on (b)(6) 2024.The case was completed successfully with no harm to the patient.There was no case delay reported and no adverse effects on the patient.Additional information was received on 01/10/2025: the ar-9236-03pp univers vaultlock¿ glenoid trial had the central post break off in the patient and was retrieved.The ar-9215-1-03 universal quick connect handle had the handle tip break off into the glenoid drill guide.After further investigation, ar-9231-vl-03 univers vaultlock glenoid drill guide had no damage found.The failure occurred during the insertion of the ar-9236-03pp univers vaultlock¿ glenoid trial.

• 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: 21217403
• Report Number: 1220246-2025-00047
• Device Sequence Number: 11594716
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: 00888867350021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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