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	Insufficient Information (4580)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl procedure, at the moment that the ar-1204af-105, makes contact with the tibial bone, the tip of the ar-1204af-105, broke within the joint space.The fragment was removed and the case was completed by using a new ar-1204af-105 without further issue.
Additional Manufacturer Narrative
- it was reported that the device broke during the procedure.- visual evaluation identified that the cutter tip had fractured off the distal end of the device.However, without the return of the device, further investigation cannot be performed.Additionally, patient bone quality and surgical technique were not reported.- the root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while prying / leveraging the device.- the reported event is confirmed based on the investigation of the returned pictures.

• 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: 11602653
• Report Number: 1220246-2021-02827
• Device Sequence Number: 3157430
• Product Code: HWE
• UDI-Device Identifier: 00888867004122
• UDI-Public: 00888867004122
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 10.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-105
• Device Lot Number: 0086102449
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1