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

Model Number	KNOTLESS TENSIONABLE FIBERTAK BICEPS KIT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/12/2025, it was reported by a sales representative via (b)(4) that an ar-3688 knotless fibertak biceps implant system blue shuttle stitch was already cut and made the anchor unusable.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 3/28/2025: during a bicep tenodesis surgery, the issue was encountered with the anchor while it was inside the patient.The suture became damaged during the insertion process, despite the anchor holding firmly due to the patient's solid bone quality.The anchor remained in the patient, and no fragments broke inside.To complete the procedure, an ar-2324bcc biocomposite swivelock c was opened and used successfully.The case experienced a slight delay of approximately 5 minutes, likely requiring additional anesthesia to accommodate the extended time.No instrument was used to prepare the bone socket, as the anchor was self-punching.
Additional Manufacturer Narrative
Additional information: b5, 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 mishandling the device causing damage/cut to suture.

• Brand Name: KNOTLESS TENSIONABLE FIBERTAK BICEPS KIT
• 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: 21760878
• Report Number: 1220246-2025-01192
• Device Sequence Number: 8455794
• Product Code: MBI
• UDI-Device Identifier: 00888867398740
• UDI-Public: (01)00888867398740(11)241029(17)290930(10)15339355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K222161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: KNOTLESS TENSIONABLE FIBERTAK BICEPS KIT
• Device Catalogue Number: AR-3688
• Device Lot Number: 15339355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown