MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATION FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Codes	Positioning Failure (1158); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2025
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 07/23/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3633sp self-punching triple loaded fibertak stuck out a little from the bone.This occurred during use.There was no additional information provided, and additional information has been requested.
Event or Problem Description
Additional information was provided on 09/26/2025 where it was reported that this event occurred during a shoulder arthroscopy for rotator cuff repair, using fibertak 2.6 mm anchors and swivellock 4.75x22 mm anchors.An instrument was used to prepare the bone.The device was used to complete the procedure.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photo provided, which shows the ar-3633sp self-punching triple loaded fibertak sticking out from the bone.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 error of the device due to excessive force used during suture passing/tightening /tensioning.Dfu-0054-eo: avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.

• Brand Name: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Common Device Name: NON-DEGRADABLE FIXATION 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: 22751778
• Report Number: 1220246-2025-03379
• Device Sequence Number: 21222010
• Product Code: MBI
• UDI-Device Identifier: 00888867369962
• UDI-Public: (01)00888867369962(11)241119(17)291031(10)15350202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200341
• 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,Followup
• Report Date (Section B): 12/09/2025

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 15350202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided; 12/07/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/07/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown