MAUDE Adverse Event Report: ARTHREX, INC. DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO; DEPTH GAUGE

Model Number	DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/24/2024, it was reported by an arthrex subsidiary employee via (b)(6) that an ar-8943-15 depth device has the tip unsoldered.This occurred during use.There was no additional information was provided, and additional information has been requested.
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 prying/leveraging the device during use.

• Brand Name: DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
• Common Device Name: DEPTH GAUGE
• 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: 20570245
• Report Number: 1220246-2024-08340
• Device Sequence Number: 7459311
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: (01)00888867052253(11)220823(10)012226
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
• Device Catalogue Number: AR-8943-15
• Device Lot Number: 012226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2022
• 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