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

Model Number	MENISCAL ROOT KIT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
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.Per customer the device will not be returned.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
The flipcutter in the ar-4550 kit was being used during the meniscal root repair.After it was drilled into the tibia, the flipcutter fell apart into four pieces.Three of the four pieces were retrieved from the patient, the fourth piece was not removed and was visible on x-ray.They used an additional incision to try and get the last piece but were unsuccessful; it is in the posterior lateral part of the knee.The case was completed; patient is male, (b)(6) years old.

• 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: 9255228
• Report Number: 1220246-2019-01383
• Device Sequence Number: 13922962
• Product Code: GAT
• UDI-Device Identifier: 00888867217379
• UDI-Public: 00888867217379
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 02/29/2024
• Device Model Number: MENISCAL ROOT KIT
• Device Catalogue Number: AR-4550
• Device Lot Number: 10315344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR