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

Model Number	LOW-PROFILE AC REPAIR SYSTEM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-2371 low-profile ac repair system had an issue.The device was initially used on (b)(6) 2021 during an ac shoulder joint reconstruction, no issues were reported and the procedure was completed successfully with no impact to the patient.The patient had a few month of physical therapy, and 2-3 months post operatively he noticed the clavicle started to rise again.The doctor scheduled x-rays, the clavicle was raised again, the 2 buttons had come undone, and the device had lost all tension.A revision surgery was performed by the same surgeon (who performed the first surgery) on (b)(6) 2022, and it was found that the suture between the two buttons had broken.They pulled out the clavicle button and they left the second button which was seated underneath the coracoid in the patient.The doctor did not want to use the same system, so he used new sutures ( ar-7237, lot number unknown, and another product from a competitor) and a graft, and tied the graft to the clavicle with the new sutures.The procedure was completed successfully with no further impact to the patient.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 13994802
• Report Number: 1220246-2022-04680
• Device Sequence Number: 20128244
• Product Code: HTN
• UDI-Device Identifier: 00888867256637
• UDI-Public: 00888867256637
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052776
• 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
• Report Date (Section B): 04/04/2022

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 Expiration Date: 11/30/2025
• Device Model Number: LOW-PROFILE AC REPAIR SYSTEM
• Device Catalogue Number: AR-2371
• Device Lot Number: 12229069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/04/2022
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown