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	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, it was reported by an arthrex employee via email that for an ar-8943-15, depth device, 2.7 / 3.5 / 4.0 mm, low profile and an ar-2670, 2.7mm screw depth indicator, these 2 depth gauges in the clavicle fracture tray were inaccurate.This caused inaccuracies in screw length measured.This was detected during a clavicle fracture procedure on (b)(6) 2026.The procedure was completed successfully as they had to use x-ray to guess the appropriate screw length.4 screws were wasted due to wrong measurement, and the screws were too long.On (b)(6) 2026 - the 4 screws used were ar-8835-20 x 2, ar-8835-24 x 1 and ar- 8835l-20 x 1.They replaced the 4 screws that were too long in the primary surgery.As both the depth devices were unable to provide proper measurement, they had to rerevise by putting shorter screws and performing an x-ray check which caused the surgery to take longer than it was supposed to.The complaint initiator thinks it took longer than 15 minutes because the nurse went out to search for possible peel depth gauge and came back with no luck.The surgeon tried many times to get the correct length as well.They used x-ray multiple times at different angles to make sure the screw was not too long.

• 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: 24441818
• Report Number: 1220246-2026-00906
• Device Sequence Number: 18735064
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: (01)00888867052253(11)190612(10)011922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/15/2026

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
• Device Lot Number: 011922
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2019
• 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