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

Model Number	9.5 MM FLIP CUTTER II
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via phone that an ar-1204af-95 flipcutter after drilling one tunnel we had issues with the drill flipping, the blade was stuck in the open position.The surgeon used a number of tools to close the cutting blade and remove the device from the patient.This was discovered during use in a procedure on (b)(6) 2022. the case was completed by using a new flipcutter to drill the second tunnel.Additional information 1/18/2022: on (b)(6) 2022 it was reported by a sales representative via email that an ar-1204af-95 flipcutter after drilling the blade was stuck in the open position.The surgeon used a number of tools to close and remove the ar-1204af-95.The surgeon drilled femoral tunnel and after removing the flipcutter had issues opening and closing the device.The surgeon used a different flipcutter to avoid any further issues and the case was completed.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: 9.5 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13397937
• Report Number: 1220246-2022-04379
• Device Sequence Number: 5893147
• Product Code: HWE
• UDI-Device Identifier: 00888867004276
• UDI-Public: 00888867004276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: 06/30/2024
• Device Model Number: 9.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-95
• Device Lot Number: 919195336
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/31/2022
• Date Device Manufactured: 08/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown