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 Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/22/2023, it was reported by a sales representative via email that the fibertak anchor from an ar-3688 knotless fibertak biceps implant system would not go down the drill guide and broke the anchor inserter.This was discovered during a subpec tenodesis procedure on (b)(6) 2023.Additional information received indicated the drill guide was inside the patient, and the fibertak inserter was inside the drill guide when it broke; however, the fragments of the fibertak were contained inside the drill guide, and nothing was loose inside the patient.The case was completed by using an ar-1665bcsl 4.75 bc loop 'n' tack¿ tenodesis implant system.The case was delayed ten minutes without needing additional anesthesia.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not returned.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 quality of the bone encountered was 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: 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: emily shafer ; 8009337001
• MDR Report Key: 18528247
• Report Number: 1220246-2024-00367
• Device Sequence Number: 7597409
• Product Code: MBI
• UDI-Device Identifier: 00888867398740
• UDI-Public: 00888867398740
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/16/2025

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: 15164775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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