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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 06/10/2025, a sales representative reported via phone that (2) ar-7534 fiberloop® 1.3mm suture tape sutures broke on both.This occurred during a distal biceps repair on (b)(6) 2025.The suture broke.All fragments of the sutures were retrieved.One of the buttons remained in place, and the other button remained in the canal.There was a delay of about 20 minutes to get a new kit and redo everything; it is uncertain if additional anesthesia was administered.There was no harm to 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 for the reported failure can be attributed to user error of the device due to either excessive force used during suture passing or the device coming in contact with another device during use.

• 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: 22414217
• Report Number: 1220246-2025-02746
• Device Sequence Number: 18212067
• Product Code: GAT
• UDI-Device Identifier: 00888867288829
• UDI-Public: (01)00888867288829(11)240205(17)290131(10)15119323
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• 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): 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: 15119323
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown