MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 9.5MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
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 procedure after the doctor drilled the first tunnel, the ar-1204as-95 flip cutter was stuck in the open position.The surgeon removed the flip cutter by snapping the top jaw, all pieces were removed.The second tunnel was drilled and the same issue occurred the surgeon drilled a full tunnel and removed the flip cutter by breaking the top jaw.

• Brand Name: FLIPCUTTER II, SHORT 9.5MM
• 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: 8535441
• Report Number: 1220246-2019-01061
• Device Sequence Number: 361023
• Product Code: HWE
• UDI-Device Identifier: 00888867004443
• UDI-Public: 00888867004443
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: No Information
• Device Expiration Date: 12/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 9.5MM
• Device Catalogue Number: AR-1204AS-95
• Device Lot Number: 901489778
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• 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