MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-2323PSLC
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of shoulder anchor broke off in the bone.Remaining parts of anchor will be sent to risk management.The tip of anchor remained in shoulder.Decision was made to keep tip in bone.

• Brand Name: ARTHREX®
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 9472988
• Report Number: 9472988
• Device Sequence Number: 2852319
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: (01)00888867026797(30)01(17)240831(10)10372821
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019
• Report Date (Section F): 12/05/2019

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: AR-2323PSLC
• Device Catalogue Number: AR-2323PSLC
• Device Lot Number: 10372821
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2019
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 12/05/2019