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

Model Number	AR-3632
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During left shoulder arthroscopic procedure, a 2.6mm arthrex fibertak suture anchor (ref # ar-3632, lot # 15036292, exp.11/30/2023), double-loaded with 1.3mm suturetape was used.During the procedure it was noted that very tip of the anchor (approximately 1mm x 2mm in size) was missing and had broken off in the bone.The surgeon indicated that the tip was approximately 1mm x 2mm in size) had broken off in the bone.The surgeon indicated that the tip was unretrievable and determined that it would be safer for the patient to leave the tip piece in place instead of trying to retrieve it.

• Brand Name: ARTHREX
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 16760851
• Report Number: 16760851
• Device Sequence Number: 19591601
• Product Code: MBI
• UDI-Device Identifier: 00888867276901
• UDI-Public: (01)00888867276901(17)231130(10)15036292
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/14/2023
• Report Date (Section F): 04/14/2023

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-3632
• Device Catalogue Number: AR-3632
• Device Lot Number: 15036292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White
• Date Report Sent to FDA: 04/14/2023