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

Model Number	AR-1927BCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure a anchor broke off in the patient.All pieces retrieved and saved.New anchor opened and used.

• 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: 9871215
• Report Number: 9871215
• Device Sequence Number: 13584494
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: (01)00888867251267(17)211130(10)10525699
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020
• Report Date (Section F): 02/20/2020

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-1927BCT
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 10525699
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 96
• Date Report Sent to FDA: 02/20/2020