MAUDE Adverse Event Report: ARTHREX, INC. 11.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 11.0 MM FLIP CUTTER II

Device Problems Break (1069); Material Disintegration (1177)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

The surgeon had three flipcutter ii disintegrate in the knee as drilling femoral tunnel.The first time they started drilling with blade on bone and the rep instructed them to start the drilling at full speed before pulling back onto the bone.But the same thing happened on the second and the third time.The patient was a 17 year old male.On all three occasions, the metal pieces of the device broke off and needed to be retrieved by the surgeon.

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.

Manufacturer Narrative

The complaint is confirmed based on the customer provided photo, which displays the damage of the cutter tip.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: 11.0 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15445979
• MDR Text Key: 300582676
• Report Number: 1220246-2022-05513
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 811082732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1