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

Model Number	SUTURETAPE TIGERLOOP W/ NDL WH/BLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
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 16-dec-2025, it was reported by an arthrex subsidiary employee via email that an ar-7534t tigerloop experienced an issue.After the graft was sutured, the tape broke.All suture material was retrieved, and the surgery was completed using the product as intended.No significant surgery delay was reported, and no additional anesthesia was administered.No adverse patient effects were reported during or following the procedure due to this issue.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 23-dec-2025: this issue occurred while the ar-7534t tigerloop was in the patient.After the sutures broke, only the broken fragments were removed, as the remaining portion still appeared to contribute to the fixation of the tendon.
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 a use error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: SUTURETAPE TIGERLOOP W/ NDL WH/BLK
• 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: 23960586
• Report Number: 1220246-2026-00063
• Device Sequence Number: 9528538
• Product Code: GAT
• UDI-Device Identifier: 00888867288867
• UDI-Public: (01)00888867288867(11)250604(17)290228(10)15194571
• 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
• Report Date (Section B): 04/17/2026

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 TIGERLOOP W/ NDL WH/BLK
• Device Catalogue Number: AR-7534T
• Device Lot Number: 15194571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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