MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE FIBERLOOP W/ NDL WH/BL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE FIBERLOOP W/ NDL WH/BL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
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 22-jan-2026, it was reported by a sales representative via email that two ar-7534 fiberloop 1.3 mm suture tape sutures became unswaged at the suture junction.This did not impact the outcome of the case, as an ar-7534 from a different lot was used to complete the procedure.This issue was discovered during a procedure on (b)(6) 2026.
Additional Manufacturer Narrative
Additional information: b3, g3, h3, h6 the device associated with the reported event was not returned for evaluation.Based on the documented event information, including available photographs, videos, event descriptions, and any additional field data, the most likely cause of the reported device breakage is use error, including incorrect surgical technique.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: SUTURETAPE FIBERLOOP W/ NDL 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: 24313254
• Report Number: 1220246-2026-00529
• Device Sequence Number: 20052453
• Product Code: GAT
• UDI-Device Identifier: 00888867288829
• UDI-Public: (01)00888867288829(11)250423(17)290930(10)15313896
• 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): 05/20/2026

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: SUTURETAPE FIBERLOOP W/ NDL WH/BL
• Device Catalogue Number: AR-7534
• Device Lot Number: 15313896
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown