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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 12-jan-2026, it was reported by an arthrex employee via (b)(4) that an ar-8943-15 depth device from an rar-9943s loaner ankle fracture set sn: 14188044 had a broken threaded ring that keeps the stick in place.It was reported that they were unsure if the ring happened to be the wrong size or was actually broken.This was discovered during a procedure with 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.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including damage to the device due to mishandling.The complaint allegation was confirmed based on the customer's attached video, which shows the device's needle detached from the shaft.Damage to the device will prevent the device from working as intended.

• 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: 24238668
• Report Number: 1220246-2026-00359
• Device Sequence Number: 8980934
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: 00888867052253
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
• Device Catalogue Number: AR-8943-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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