MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a posterior bankart surgery the tip of the device broke when being inserted with the hammer although the surgeon pre-drilled and used a guide.The tip could not be removed from the patient.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.

• Brand Name: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22123368
• Report Number: 1220246-2025-02321
• Device Sequence Number: 20626988
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Device Catalogue Number: AR-3603-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown