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	Insufficient Information (4580)
Date of Event	06/16/2025
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
It was reported that during an ankle joint surgery the device broke at the weld seam.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The reported event was confirmed as the evaluation of the received ar-8943-15 with batch 012445 revealed that the instrument's needle was detached at the weld (see evaluation picture 2).No functional test was performed for the instrument due to the damage.The most likely cause is misuse due to user error of using excessive force to pry and leverage the device.

• 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: 22484749
• Report Number: 1220246-2025-02837
• Device Sequence Number: 12900179
• Product Code: HTJ
• UDI-Device Identifier: 00888867052253
• UDI-Public: (01)00888867052253(11)241118(10)012445
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 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: 012445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Distributor Facility Aware Date: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown