MAUDE Adverse Event Report: ARTHREX, INC. BUTTON, DOG BONE; WASHER, BOLT NUT

Model Number	BUTTON, DOG BONE
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/15/2020
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.
Event or Problem Description
It was reported that the patient had an ac separation that was initially treated with the ar-2270 dog bone implant.A few weeks later, the anchor in the corocoid had pulled out and was revised using a clavicle hook plate.

• Brand Name: BUTTON, DOG BONE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11591179
• Report Number: 1220246-2021-02798
• Device Sequence Number: 14220894
• Product Code: HTN
• UDI-Device Identifier: 00888867026599
• UDI-Public: 00888867026599
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: BUTTON, DOG BONE
• Device Catalogue Number: AR-2270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other