MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE 1.3 W/TPR NDL 36.6MM 1/2 CRL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE 1.3 W/TPR NDL 36.6MM 1/2 CRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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 10/30/2024, it was reported by a sales representative via email that the needle from an ar-7506 suturetape popped off.This was discovered during a procedure.No further information was reported.Additional information received on 11/15/2024: the needle popped off while the surgeon used it on the patient during a sub pec biceps tenodesis procedure.All the broken fragments were removed.The case was completed using a new ar-7506 suturetape.The case was insignificantly delayed with no additional anesthesia needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening/tensioning.

• Brand Name: SUTURETAPE 1.3 W/TPR NDL 36.6MM 1/2 CRL
• 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: 20915646
• Report Number: 1220246-2024-08833
• Device Sequence Number: 8581127
• Product Code: GAT
• UDI-Device Identifier: 00888867288843
• UDI-Public: (01)00888867288843(11)240216(17)281031(10)15097105
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193575
• 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): 06/16/2025

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 1.3 W/TPR NDL 36.6MM 1/2 CRL
• Device Catalogue Number: AR-7506
• Device Lot Number: 15097105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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