MAUDE Adverse Event Report: ARTHREX, INC. PARS SUTURE IMPLANT KIT W/ SUTURETAPE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	PARS SUTURE IMPLANT KIT W/ SUTURETAPE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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 10/22/2024, it was reported by a sales representative via email that the green fiberlink sutures from an ar-8862ds pars suturetape implant system were ripped and were not able to complete the locking stitch.A second kit was opened to complete the case.The case was delayed about five minutes.This was discovered during a procedure on (b)(6) 2024.
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: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• 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: 20611842
• Report Number: 1220246-2024-08409
• Device Sequence Number: 12610655
• Product Code: GAT
• UDI-Device Identifier: 00888867288263
• UDI-Public: (01)00888867288263(11)240329(17)290228(10)15227058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Device Catalogue Number: AR-8862DS
• Device Lot Number: 15227058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• 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