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

Model Number	AR-1678-CP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, a peek anchor broke while being inserted.Report was negative for foreign body and case was finished without further incident.

• 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: 18570544
• Report Number: 18570544
• Device Sequence Number: 15238740
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: (01)00888867020887
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/10/2023
• Report Date (Section F): 10/10/2023

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-1678-CP
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 15063593
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/10/2023