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

Model Number	MENISCAL ROOT KIT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2020
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.
Event or Problem Description
An arthrex employee has reported that after the successful meniscus root fixation the surgeon wanted to knot the button on the bone.The button fell into the drill hole.The surgeon then tried to refixate the suture with a push lock but it ruptured.The surgeon was then able to finish the surgery successfully with a different technique and an additional swivelock.However the surgeon was not able to retrieve the lost button out of the patient.

• 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: 10443229
• Report Number: 1220246-2020-02089
• Device Sequence Number: 2452454
• Product Code: GAT
• UDI-Device Identifier: 00888867217379
• UDI-Public: 00888867217379
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: 11/30/2024
• Device Model Number: MENISCAL ROOT KIT
• Device Catalogue Number: AR-4550
• Device Lot Number: 10823972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other