MAUDE Adverse Event Report: Arthrex, Inc. SUTURETAPE 0.9mm w/2 Curved NDLs WH/BLK; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE 0.9mm w/2 Curved NDLs WH/BLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 9 sep 2026, it was reported by an arthrex employee via email that a ar-7572-02 str tp 0.9mm w/2 crvd 26.5mm ndls wh/blu and a ar-7572t-02 suturetape 0.9mm w/2 curved ndls wh/blk 's suture broke.This was discovered upon inspection after knot tying, rendering the repair unsuccessful.This occurred during a knee ligament and meniscus repair procedure where the devices were used to repair the ligaments and the meniscus within the knee joint.There were no anomalies observed during the suturing and knot-tying process, and it appears the tape broke when tension was applied to the tissue.The surgery was completed successfully by using a product with the same part number.All of the product/fragment was removed, and nothing remains in the patient.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTURETAPE 0.9mm w/2 Curved NDLs WH/BLK
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50867055
• Report Number: 1220246-2026-04859
• Device Sequence Number: 10715088
• Product Code: GAT
• UDI-Device Identifier: 00888867404557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221354
• 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
• Report Date (Section B): 09/23/2026

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 0.9mm w/2 Curved NDLs WH/BLK
• Device Catalogue Number: AR-7572T-02
• Device Lot Number: 15221531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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