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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2024, a sales representative reported via (b)(4) that an ar-8943-15 depth device had the 3.5 sliding depth gauge from the wrist plating set appearing to be broken during a case.When grabbing from the set, they noticed it would not slide correctly.After taking it apart, they saw that the welded part, where the depth wire meets the measuring section, was broken into two pieces.No pieces broke off inside the patient and the case was completed successfully.This was discovered during a distal radius repair procedure on (b)(6) 2024, with no reported 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.The complaint device was not received for evaluation.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 concluded that the most likely cause of the reported failure is user error, including failure to inspect the instrument prior to use.The complaint allegation was not confirmed, and no evidence of the failure was received.

• 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: 21217836
• Report Number: 1220246-2025-00052
• Device Sequence Number: 20992572
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: (01)00888867052253(11)230111(10)012301
• 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,Followup
• Report Date (Section B): 09/04/2025

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: 012301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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