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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 244856357
• Report Number: 1220246-2021-02827
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004122
• UDI-Public: 00888867004122
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1