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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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 (b)(6) 2025, an employee from an arthrex subsidiary reported via email that an ar-7534t tigerloop experienced a failure.After the device was passed through the bone tunnel, one side of the tape broke during extension and flexion.The surgery, an acl reconstruction performed on (b)(6) 2025, was completed using only the tigerloop without the use of any additional products.No significant delay in the procedure was reported, no additional anesthesia was administered, and no adverse effects were observed in the patient during or following the surgery as a result of this issue.Additional information was received on 11/11/2025: the broken tapes were removed from the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to improper bone preparation, excessive force used during suture passing, or the device coming in contact with another device during use.

• 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: 23632693
• Report Number: 1220246-2025-05167
• Device Sequence Number: 9337687
• Product Code: GAT
• UDI-Device Identifier: 00888867288867
• UDI-Public: 00888867288867
• 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): 03/10/2026

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown