MAUDE Adverse Event Report: ARTHREX, INC. FIBERRING WITH SHUTTLE LOOP 25MM, 12PACK; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERRING WITH SHUTTLE LOOP 25MM, 12PACK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-1588r-ib acl repair tightrope and (2) ar-7282-25 fiberring sutures were being assembled when the rightrope broke while tensioning.The case was completed using another ar-1588r-ib acl repair tightrope and (2) ar-7282-25 fiberring sutures.This was discovered during a primary aclr procedure on (b)(6) 2023.
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
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 fraying can be attributed to use error of the device due to excessive force being used when tensioning the sutures.

• Brand Name: FIBERRING WITH SHUTTLE LOOP 25MM, 12PACK
• 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: 17549745
• Report Number: 1220246-2023-07507
• Device Sequence Number: 15167133
• Product Code: GAT
• UDI-Device Identifier: 00888867363687
• UDI-Public: 00888867363687
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 01/10/2025

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 LOOP 25MM, 12PACK
• Device Catalogue Number: AR-7282-25
• Device Lot Number: 100003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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