MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH SUTURETAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK WITH SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/5/2025, an fda medwatch notification was received via email.A facility representative reported that an ar-3602 fibertak tip broke upon insertion into the patient's shoulder.Two pieces from the broken tip were retrieved.The pieces were compared to an identical implant showing identical size and length.An x-ray confirmed that no foreign body was retained.The surgery was completed with a new fibertak.This was discovered during a right shoulder arthroscopy, labral repair vs debridement, possible biceps tenodesis, possible open surgery procedure in (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: FIBERTAK WITH SUTURETAPE
• 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: 21644350
• Report Number: 1220246-2025-01029
• Device Sequence Number: 7756541
• Product Code: MBI
• UDI-Device Identifier: 00888867206946
• UDI-Public: (01)00888867206946(11)240913(17)290831(10)15316931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 SUTURETAPE
• Device Catalogue Number: AR-3602
• Device Lot Number: 15316931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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