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

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 08/30/2025, an arthrex subsidiary employee reported via email that an ar-3600 fibertak suture anchor experienced an issue.After the anchor was placed following the correct steps, a gentle pull was performed to verify placement.As a result, the anchor came out.Upon inspection, it was found to be torn (see photo attachment).The case was completed; however, no specific details were provided regarding how it was finalized.This issue was discovered during a shoulder arthroscopy procedure performed on (b)(6)2025, with no reported patient harm.Additional information has been requested on 09/08/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the photographic evidence submitted for evaluation of an ar-3600 fibertak¿ suture anchor, batch 15399127.The image shows damage to one end of the implant.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported issue.The most likely cause is attributed to use-related factors, such as: insufficient bone quality.Improper tunnel preparation.Misalignment during insertion.Excessive tension was applied.

• Brand Name: FIBERTAK SUTURE 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: 23086108
• Report Number: 1220246-2025-03925
• Device Sequence Number: 18767502
• Product Code: MBI
• UDI-Device Identifier: 00888867101890
• UDI-Public: (01)00888867101890(11)250304(17)300228(10)15399127
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K181769
• 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): 01/28/2026

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 SUTURE ANCHOR
• Device Catalogue Number: AR-3600
• Device Lot Number: 15399127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown