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	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/05/2025, it was reported by a sales representative via (b)(4) that an ar-9215-1-03 quick connect handle is broken.This occurred during use in a case with no patient effect.No delay to case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-9215-1-03 universal quick connect handle batch number: 04512201 was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with superficial discoloration and faded laser markings observed.It was further noted that the tip of the device was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 24-jan-2022.Refer to investigation photos.Complaint allegation is confirmed.

• 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: 21645165
• Report Number: 1220246-2025-01034
• Device Sequence Number: 7564751
• Product Code: LXH
• UDI-Device Identifier: 00888867350021
• UDI-Public: 00888867350021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/13/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown