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	02/06/2025
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 february 7, 2025, a sales representative reported via sems-06777612 that an ar-9215-1-03 universal quick connect handle locking part broke off when the cutting block rotated during drilling.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on february 13, 2025: this occurred during an eclipse total shoulder arthroplasty procedure on (b)(6) 2025.They used an additional handle in their sets to complete the case.A vaultloack was used to complete the case.There was no case delay or added anesthesia administered to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal tip of the returned universal quick connect handle assembly had broken off.Rust spots have been observed on the knurled areas of the device.Functional testing was not performed due to the device's damage.The most likely cause of this failure is wear and tear damage caused by user-applied excessive mechanical forces incurred over repeated usage in the field.

• 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: 21422200
• Report Number: 1220246-2025-00571
• Device Sequence Number: 15501210
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: (01)00888867350021(11)211109(10)04512139
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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