MAUDE Adverse Event Report: ARTHREX, INC. MENISCAL ROOT KIT; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	MENISCAL ROOT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that a knee scorpion needle from an ar-4550 meniscal root repair implant system was damaged and broken; the surgeon was able to remove all broken fragments.As a result, the meniscal root repair was not completed.The surgeon changed to an all-inside procedure, in which three consecutive ar-4570 fiberstitch could not deploy the second implant due to the wheel getting stuck.The first anchor for each fiberstitch was removed from inside the patient.The case was conducted using a product from another manufacturer.This was discovered during a procedure on (b)(6) 2023.
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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: MENISCAL ROOT KIT
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16501093
• Report Number: 1220246-2023-06396
• Device Sequence Number: 15007985
• Product Code: GAT
• UDI-Device Identifier: 00888867217379
• UDI-Public: 00888867217379
• 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): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: MENISCAL ROOT KIT
• Device Catalogue Number: AR-4550
• Device Lot Number: 14603662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown