MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE FIBERLINK 1.3MM WH/BL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE FIBERLINK 1.3MM WH/BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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 12/10/2024, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-4068-45l suturelasso¿ sd had an issue while shuttling an ar-7535 fiberlink suturetape stitch.The surgeon passed the sd suture lasso around the labrum and left the sd wire in place to shuttle a stitch around.Upon shuttling, a stitch through the wire loop broke, and the surgeon retrieved the stitch (ar-7535 fiberlink suturetape) around the labrum.No pieces broke off inside the patient.The surgeon inserted the pushlock anchor (ar-2923bc) to complete that part of the repair.This issue happened twice more during the case (see photos).This was discovered during a labrum repair procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 12/14/2024: the wire loop of the (qty.2) of an ar-4068-45l suturelasso did not break, and no pieces broke off.There was no case delay reported.No reported adverse effects on the patient due to the issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.The most likely cause for the reported failure can be attributed to use error of the concomitant device (ar-4068-45l suturelasso¿ sd) likely due to user-applied excessive mechanical forces.

• Brand Name: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 21084996
• Report Number: 1220246-2025-09231
• Device Sequence Number: 20929221
• Product Code: GAT
• UDI-Device Identifier: 00888867288669
• UDI-Public: 00888867288669
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• 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): 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: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Device Catalogue Number: AR-7535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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