MAUDE Adverse Event Report: ARTHREX, INC. QUICK CONNECT HANDLE, ASSEMBLY; LXH

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 during use with the secondary guide drilling.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 03/27/2025: the device broke inside the patient.All fragments were removed from the patient.There was no case delay reported.The broken handle was replaced using another handle included in the set, and it is unknown if additional anesthesia was administered.No adverse effects were reported.This occurred during an anatomic total shoulder procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-9215-1-03, universal quick connect handle, serial/batch number (b)(6), was received for investigation.Upon visual inspection, it was observed that the tip of the device was broken.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• Brand Name: QUICK CONNECT HANDLE, ASSEMBLY
• Common Device Name: LXH
• 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: 21765285
• Report Number: 1220246-2025-01208
• Device Sequence Number: 15569153
• Product Code: ORT
• UDI-Device Identifier: 00888867350021
• UDI-Public: (01)00888867350021(11)211109(10)04512139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 04512139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown