MAUDE Adverse Event Report: ARTHREX, INC. FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery the suture of the implant ar-1588r-ib (lot: 15088451) did not pull through the loop on the button.The rings ar-7282-25-1 (lot: 100001) failed (were not usable) due to the failure of the button.All devices were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 08-dec-2023 it was confirmed that the device was actually intact, but had to be discarded in the end because the implant ar-1588r-ib (lot: 15088451) failed.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is 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 excessive force used during suture passing/tightening /tensioning.

• Brand Name: FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18438214
• Report Number: 1220246-2024-00060
• Device Sequence Number: 20606125
• Product Code: GAT
• UDI-Device Identifier: 00888867363694
• UDI-Public: 00888867363694
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• 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): 01/30/2025

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: FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE
• Device Catalogue Number: AR-7282-25-1
• Device Lot Number: 100001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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