MAUDE Adverse Event Report: ARTHREX, INC. LOW-PROFILE AC IMPLANT DEVICE; WASHER, BOLT, NUT

Model Number	LOW-PROFILE AC IMPLANT DEVICE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/13/2025, an arthrex subsidiary employee reported via email that a patient previously had an ar-2370 low-profile ac implant implanted during an ac joint dislocation repair on (b)(6) 2025.Two months later, it was discovered that the ar-2370 low-profile ac implant had broken inside the patient.A revision surgery was performed on (b)(6) 2025, during which the product was removed, and a new ar-2370 low-profile ac implant was implanted.The revision surgery was completed without incident, and no issues have been reported.Additional information has been requested on 06/02/2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 06/03/2025: only the ar-2370 low-profile ac implant was implanted during the initial surgery and then extracted during the revision.It is unknown when the issue was noticed after initial implantation.Due to the broken implant, joint dislocation, and discomfort were reported.No health issues have been reported to date after the revision.No postoperative or preoperative x-ray was available.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to a patient-specific event.

• Brand Name: LOW-PROFILE AC IMPLANT DEVICE
• Common Device Name: WASHER, BOLT, NUT
• 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: 22134046
• Report Number: 1220246-2025-02353
• Device Sequence Number: 18003440
• Product Code: HTN
• UDI-Device Identifier: 00888867369870
• UDI-Public: (01)00888867369870(11)241122(17)291031(10)15352178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052776
• 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,Followup
• Report Date (Section B): 10/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LOW-PROFILE AC IMPLANT DEVICE
• Device Catalogue Number: AR-2370
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided; 10/01/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/23/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown