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

Model Number	MENISCAL ROOT KIT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a procedure, the tip of the knee scorpion needle broke off during suture passing step of lateral meniscal root repair.All fragments were removed and the case was completed by suing a new kit.
Additional Manufacturer Narrative
It was reported that the needle broke during use.The reported event is confirmed upon investigation of the returned picture.Visual evaluation identified that the tip of the device broke.However, without the return of the device or a better quality picture, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon 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
• MDR Report Key: 11435839
• Report Number: 1220246-2021-02672
• Device Sequence Number: 16858205
• 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): 03/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: MENISCAL ROOT KIT
• Device Catalogue Number: AR-4550
• Device Lot Number: 12030493
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1