MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 8MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/10/2019
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.The device was reported to have been discarded.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 during an acl post op x-ray the tip of the flip cutter was discovered inside the patient.A revision is scheduled for (b)(6) 2019 to remove the foreign body.The patient is a 13 year old male.The doctor stated the outcome of the procedure was successful and the revision is solely to remove the tip from the knee.Additional information obtained (12/10/2019): the second procedure to remove the tip of the flip cutter was performed on (b)(6) 2019 as scheduled and it was retrieved successfully with no complications.

• Brand Name: FLIPCUTTER II, SHORT 8MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506122
• Report Number: 1220246-2019-01514
• Device Sequence Number: 11508476
• Product Code: HWE
• UDI-Device Identifier: 00888867004412
• UDI-Public: 00888867004412
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/20/2019

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 Model Number: FLIPCUTTER II, SHORT 8MM
• Device Catalogue Number: AR-1204AS-80
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/20/2019
• 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