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	Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/31/2024 it was reported by a sales representative via email that an ar-3688 knotless fibertak could not be cinched down.Upon trying to reduce the knotless white loop at the end of the procedure, the surgeon encountered some resistance, and ultimately, could not reduce this stitch.The surgeon cut out the knotless fibertak and proceeded to use a new implant.This was discovered during an open rotator cuff repair procedure on (b)(6) 2024.Additional information was received on 6/7/2024.The case was completed using another ar-3688 knotless fibertak.The sutures were cut; however, some of the anchor remains in the patient.Nothing broke off in the patient.The case was slightly delayed with minimal anesthesia administration to the patient.The patient suffered no negative effects on or after the procedure.
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.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/mishandling due to damage to the device.

• 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: 19632105
• Report Number: 1220246-2024-06489
• Device Sequence Number: 7092958
• Product Code: MBI
• UDI-Device Identifier: 00888867398740
• UDI-Public: 00888867398740
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 15209562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown