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

Model Number	LOW-PROFILE AC REPAIR SYSTEM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 22nd february 2023, it was reported by a distributor via email that an ar-2371, had loosened, post-operation.This was detected during 2-month post-operative x-ray, on (b)(6)2023.A surgeon had implanted the tightrope for a clavicle fracture case on (b)(6) 2023.The ac joint was successfully reduced initially.However, from the 2-month post-operative x-ray, the surgeon discovered that the implant was loosened and hence the ac joint is once again dislocated.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the post-op x-ray revealed that the ar-2371 is no longer fixated.Complaint allegation is confirmed.The most likely cause for the reported failure can be attributed to a patient-specific event.Refer to reference photos attached.

• Brand Name: LOW-PROFILE AC REPAIR SYSTEM
• 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: 18850308
• Report Number: 1220246-2024-01326
• Device Sequence Number: 7140545
• Product Code: HTN
• UDI-Device Identifier: 00888867256637
• UDI-Public: 00888867256637
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOW-PROFILE AC REPAIR SYSTEM
• Device Catalogue Number: AR-2371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown