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

Model Number	MENISCAL ROOT KIT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2018
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 disposition is unknown and the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was discovered during monthly maude review that a facility had reported the following: the arthrex component of an ar-4550, knee scorpion needle, had the tip break off in patient's knee joint during surgery and was seen on x-ray post op.Surgeon chose to monitor patient and not go in after the tip.Maude report contained no facility or reporter name/contact information.Therefore no follow up is possible.

• Brand Name: MENISCAL ROOT KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7691664
• Report Number: 1220246-2018-00549
• Device Sequence Number: 2580160
• Product Code: GAT
• UDI-Device Identifier: 00888867217379
• UDI-Public: 00888867217379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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 Model Number: MENISCAL ROOT KIT
• Device Catalogue Number: AR-4550
• Device Lot Number: 10034428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/16/2018
• 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