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

Model Number	FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2025
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
On 28th august 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-3638, knotless fibertak¿ with #2 suture (5-box), the implant holder tip broke during being deployed.Loose pieces were retrieved during the case.This was detected during a shoulder instability repair on (b)(6) 2025.The case was completed successfully by using another implant.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the tips of the device were broken off.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 user-applied excessive mechanical forces, misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: FIBERTAK
• 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: 23084593
• Report Number: 1220246-2025-03918
• Device Sequence Number: 9812293
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: (01)00888867292123(11)241209(17)291130(10)15358672
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K130458
• 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): 12/05/2025

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
• Device Catalogue Number: AR-3638
• Device Lot Number: 15358672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown