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

Model Number	KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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 08/21/2025, a distributor reported via email that an ar-3638h knotless hip fibertak suture anchor experienced an issue in which the repair suture breaks from the anchor during passage.The case was completed with another new implant.This was discovered during a hip instability procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 08/27/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.Per dfu-0054-eo - e.Warnings - 6.Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.7.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.G.Precautions - 6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.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.7.Arthrex implant specific instrumentation must be used to insert implantable devices per the recommended surgical technique.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, or wrong surgical technique during the knotless mechanism conversion process, the device contact with another instrument during use, and/or excessive force applied during suture passage, which could compromise suture integrity.

• Brand Name: KNOTLESS HIP 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: 23018640
• Report Number: 1220246-2025-03809
• Device Sequence Number: 18584130
• Product Code: MBI
• UDI-Device Identifier: 00888867295568
• UDI-Public: (01)00888867295568(11)240409(17)290331(10)15232084
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K130458
• 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): 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: KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638H
• Device Lot Number: 15232084
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown