MAUDE Adverse Event Report: ARTHREX, INC. BALL TIP PROBE SHAFT FLEXIBLE 1.8X330MM

Model Number	BALL TIP PROBE SHAFT FLEXIBLE 1.8X330MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/03/2025, a sales representative reported via (b)(4) that an ar-s7405-018-330 ball tip probe shaft broke.This occurred during use the device broke in the patient.It took about 5 minutes to take it out of the patient.There was no patient harm.
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.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: BALL TIP PROBE SHAFT FLEXIBLE 1.8X330MM
• Common Device Name: PROBE
• 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: 21994262
• Report Number: 1220246-2025-01963
• Device Sequence Number: 4478697
• Product Code: LXH
• UDI-Device Identifier: 00888867473720
• UDI-Public: (01)00888867473720(11)240522(10)01590044
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/26/2025

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: BALL TIP PROBE SHAFT FLEXIBLE 1.8X330MM
• Device Catalogue Number: AR-S7405-018-330
• Device Lot Number: 01590044
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown