MAUDE Adverse Event Report: ARTHREX, INC. DEPTH DEVICE, 2.7/3.5/4.0MM, SLIDER ASM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DEPTH DEVICE, 2.7/3.5/4.0MM, SLIDER ASM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 29-dec-2025, it was reported by a sales representative via (b)(4) that an ar-8943-15-1 depth device is broken at the welded joint.Noticed during a case but was not broken within patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is confirmed.-one unpackaged ar-8943-15 was received for investigation.-visual inspection noted that the slider pin of the depth device, 2.7 / 3.5 / 4.0mm, low pro, was broken off.-functional testing was not performed due to the damage to the device.The cause of the reported failure is attributed to a design issue, addressed in ncr-32022.

• Brand Name: DEPTH DEVICE, 2.7/3.5/4.0MM, SLIDER ASM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24044174
• Report Number: 1220246-2026-00176
• Device Sequence Number: 9075241
• Product Code: MDM
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/05/2026

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, SLIDER ASM
• Device Catalogue Number: AR-8943-15-1
• Device Lot Number: 012506
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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