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
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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: 21084992
• Report Number: 1220246-2025-09232
• Device Sequence Number: 8386322
• 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): 08/23/2025

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: 08/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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