MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 8.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the sales rep, that during an acl repair procedure, the surgeon drilled and prepped the tibia with no issue.Upon insertion of the flipcutter, ar-1204as-85, into the joint, the surgeon noticed that the tip was bent and broken.The surgeon had to bend and break the flipcutter to get it removed from the tibia.All the pieces were removed and the case was completed using an ar-1897s guide wire set , ar-1208l, 8mm cannulated drill and ar1209l, 9mm cannulated drill.Additional information provided 5/8/2019: all fragments were removed from the original drill hole without having to create an unplanned incision.When the surgeon switched to the ar-1897s, he had to drill a full tunnel.

• Brand Name: FLIPCUTTER II, SHORT 8.5MM
• 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: 8654966
• Report Number: 1220246-2019-01119
• Device Sequence Number: 1831165
• Product Code: HWE
• UDI-Device Identifier: 00888867004429
• UDI-Public: 00888867004429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/30/2019

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: 12/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 8.5MM
• Device Catalogue Number: AR-1204AS-85
• Device Lot Number: 900489390
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/30/2019
• 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