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

Model Number	FIBERTAK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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 08/14/2025, an arthrex subsidiary employee reported via email that an ar-3638 knotless fibertak could not be used during a procedure, as it failed to pass through both the curved and straight drill guides.The case was completed utilizing a replacement ar-3638 knotless fibertak.There was no delay in the procedure, no additional anesthesia was administered, and no adverse effects were reported during or after the surgery.The event occurred on (b)(6) 2025, during an unspecified procedure, as no procedural details were provided.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3638 batch 15343771 was received for evaluation.The received device matches an ar-3636 handle; however, according to the confirmed information, it is the device associated with the allegation.Visual evaluation of the returned inserter found a bend at the distal end of the tip.The suture system was found to be frayed, and the sutures closed to the anchor show signs of stiffness and excessive force applied.Functional testing was not performed because the suture system was damaged.According to the product description: ar-3638- be aware that ar-3636 is not compatible with older curved spears, ar-2948ct.Ar-3636 "only compatible with fibertak disposable kits ar-3638ds or ar-3638dc and reusable drill guides with references ar-3610#" the most likely cause of the reported failure is a user error, including incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.

• Brand Name: 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: 22950924
• Report Number: 1220246-2025-03709
• Device Sequence Number: 9636596
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: (01)00888867292123(11)241107(17)291031(10)15343771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 15343771
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown