MAUDE Adverse Event Report: ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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
It was reported that during a shoulder surgery the suture of an ar-3641-1 has torn.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3641-1 2.6 mm knotless fibertak¿ anchor was received for investigation.Visual evaluation of the returned device noted the suture was returned disassembled and the anchor was still intact.It was further noted that a suture was missing from the assembly.Functional testing was not performed due to the damage to the device.The bone quality of the patient and the information of the instrument used to prepare the bone socket for insertion of the implant were not provided.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion and/or improper bone preparation.Refer to investigation photos.

• Brand Name: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• 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: 21643491
• Report Number: 1220246-2025-01022
• Device Sequence Number: 7614822
• Product Code: MBI
• UDI-Device Identifier: 00888867290952
• UDI-Public: (01)00888867290952(11)240523(17)290430(10)15253015
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K232973
• 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): 07/29/2025

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: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641-1
• Device Lot Number: 15253015
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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