MAUDE Adverse Event Report: ARTHREX, INC. AC JOINT CORACOID GRAFT PASSER LEFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	AC JOINT CORACOID GRAFT PASSER LEFT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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 26-jan-2026, it was reported by a sales representative via (b)(4) that an ar-2256l left shoulder coracoid passer twisted while passing under coracoid.This was discovered during an ac joint reconstruction procedure with no patient harm.The case was completed successfully.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the distal end of the shaft oriented in a different direction.The anodized surface color is faded.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 was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to wear and tear damage resulting from repeated and extended use of the device in the field.Manufacturing date 2009.

• Brand Name: AC JOINT CORACOID GRAFT PASSER LEFT
• 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 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24324194
• Report Number: 1220246-2026-00554
• Device Sequence Number: 10005147
• Product Code: MDM
• UDI-Device Identifier: 00888867026377
• UDI-Public: (01)00888867026377(10)02084603
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/01/2026

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: AC JOINT CORACOID GRAFT PASSER LEFT
• Device Catalogue Number: AR-2256L
• Device Lot Number: 02084603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/01/2026
• 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