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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/10/2025, an arthrex subsidiary employee reported via email that following the use of the ar-8862ds pars suturetape implant system to repair an achilles tendon rupture, three sutures ruptured during a dorsiflexion test intended to confirm the integrity of the repair.The procedure was successfully completed using the ar-7500 system.There was no harm to the patient.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 likely cause by damage to the sutures during insertion.

• 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: 22415272
• Report Number: 1220246-2025-02751
• Device Sequence Number: 8407970
• Product Code: GAT
• UDI-Device Identifier: 00888867288263
• UDI-Public: (01)00888867288263(11)241031(17)290930(10)15340732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171296
• 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): 10/14/2025

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: 15340732
• Was Device Available for Evaluation?: Yes
• 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: 10/08/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown