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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9215-1-03 universal quick connect handle batch 04512145 was received for evaluation.Visual inspection revealed that the instrument's tip was broken off; the fragment recovered during the event was not returned for investigation.Signs of wear and tear.A functional test was performed by pressing the handle; no resistance was detected.The most likely cause of the reported failure is user error, specifically the use of a device that may be damaged by wear and tear from repetitive reprocessing (manufacturing date: 2021).Directions for use dfu-0023-eo, revision 5, instruments.Section c.Validation.Repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to repeated use and/or reprocessing.The user assumes liability and is responsible for the use of a damaged or dirty device.
Event or Problem Description
On 13-jan-2026, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 universal quick connect handle broke during use.This was discovered during an unspecified procedure with no patient harm.Additional information provided 17-feb-2026: it was further reported this occurred during a total shoulder arthroplasty procedure.When the device was inserted into the guide, it snapped and broke off into the guide.The surgeon had to remove the broken piece out from the patient.No extra anesthesia was administered, and the patient was not harmed.The case was completed with another quick connect handle.

• 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: 24550541
• Report Number: 1220246-2026-01308
• Device Sequence Number: 5597371
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: (01)00888867350021(11)211119(10)04512145
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 03/09/2026

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: 04512145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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