MAUDE Adverse Event Report: ARTHREX, INC. 10.5 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	10.5 MM FLIP CUTTER II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2019
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 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 that patient underwent an acl procedure on (b)(6) 2019 where a flipcutter, ar-1204af-105, was used.During retro-drilling of the femoral tunnel, the cutter broke off.The cutter was unable to be retrieved and the patient was scheduled for a second surgery to have the cutter removed.The patient underwent a second surgery on (b)(6) 2019 and had the cutter removed with no incident.Additional information requested.Additional information provided (b)(6) 2019: the facility discarded both parts of the flipcutter after the case and no x-rays were taken.

• Brand Name: 10.5 MM FLIP CUTTER II
• 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: 8734620
• Report Number: 1220246-2019-01164
• Device Sequence Number: 2572450
• Product Code: HWE
• UDI-Device Identifier: 00888867004122
• UDI-Public: 00888867004122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 06/30/2023
• Device Model Number: 10.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-105
• Device Lot Number: 815983988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/26/2019
• 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