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

Model Number	KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 24 april 2025, it was reported by a sales representative via email that 2 x ar-3638h-1 knotless hip fibertak and one ar-2923ps, sutr anchpeek p-lck2.9x 12.5mm were reported to have failed during use.This occurred on (b)(6) 2025 in (b)(6) during a right hip arthroscopy & labral repair.It was reported surgeon performing a labral repair of right hip.Surgeon using knotless hip fibertak suture anchors.2x anchors deployed already into joint.Staff opened a 3rd anchor.Unfortunately, the sutures had unravelled from the inserter and were unable to be re-positioned onto the inserter.A 4th anchor was then opened and used, and unfortunately pulled straight back out.All pieces of the suture anchor removed from the joint.Surgeon then opted to use a hip pushlock anchor with 1.3mm suture tape.Upon insertion, it was noted that the eyelet broke.Likely due to suboptimal trajectory on insertion.The anchor was removed with no pieces remaining in joint.The case was completed successfully using a stryker cinclock.There was case involvement.
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.The complaint device was not received for evaluation.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 the most likely cause.The reported failure is most likely due to end-user mishandling of the device.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 21910025
• Report Number: 1220246-2025-01747
• Device Sequence Number: 17199038
• Product Code: MBI
• UDI-Device Identifier: 00888867295575
• UDI-Public: (01)00888867295575(11)240207(17)290131(10)15204200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130458
• 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
• Report Date (Section B): 08/21/2025

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-1
• Device Lot Number: 15204200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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