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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
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 4/3/2025, it was reported by an arthrex subsidiary employee via email that an ar-7534t tigerloop and ar-7534 fiberloop sutures broke when pulling on the threads with a tensionloc tensioner.This was discovered when passing the graft during an aclr procedure on (b)(6) 2025.The case was completed using a new ar-7534t tigerloop and ar-7534 fiberloop.
Event or Problem Description
Additional information received on 5/1/2025: this issue occurred while it was inside the patient.All the broken fragments were removed.The case was not delayed, and additional anesthesia was not administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, the application of excessive force during suture tensioning and/or adjusting the suture against a sharp or rough edge may result in suture breakage.A slow, steady pull is recommended to ensure the anchor seats properly.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: 21942385
• Report Number: 1220246-2025-01822
• Device Sequence Number: 9055933
• Product Code: GAT
• UDI-Device Identifier: 00888867288829
• UDI-Public: (01)00888867288829(11)240416(17)290228(10)15141313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171296
• 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,Followup
• Report Date (Section B): 10/06/2025

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 FIBERLOOP W/ NDL WH/BL
• Device Catalogue Number: AR-7534
• Device Lot Number: 15141313
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: Not provided; 09/30/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/28/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown