MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number FLIPCUTTER II, SHORT 10MM

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Date 10/03/2019

Event Type  Injury  

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.

Event Description

It was reported by the sales rep, that during a right knee arthroscopic acl, the 1st flipcutter was drilled into the femur, surgeon noticed the bone was harder than normal, it was flipped, and back drilled to the depth determined adequate by the surgeon.Because of the hard bone, the pa checked the flipcutter on the back table a couple of times to ensure it was working properly.Was satisfied, so continued with drilling through the tibia.The flipcutter came through the tibia in the correct location, the guide was removed, and drill sleeve malleted into place.Flipcutter was deploying and when the blade came into contact with bone it broke off.The piece was removed entirely from the patient.A second flipcutter was opened and checked for deployment on the back table.Everything looked normal and was introduced into the drill guide sleeve and came through the tibia in the same location.At this point the surgeon mentioned it had flipped on its own and when they tried to back drill, it seemed the inner portion was spinning but the outer portion and blade were not moving.They tried to flip the blade back, but it would not move.They tried to manually flip the blade with a ring grasper and it was stuck.While we were out of the room, in the process of trying to get the blade to flip, the surgeon had snapped it off and removed it completely from the patient.At which point the remaining parts of the flipcutter was also removed completely.The surgeon elected to drill a complete tibial tunnel and fixate the graft on the tibia with a large abs button and back it up with a swivelock.Surgeon was satisfied with the end result.

Manufacturer Narrative

Complaint confirmed, the cutter tip was found to be detached and the distal end of the device broken.Complainant's event is most likely caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces applied during use.

• Brand Name: FLIPCUTTER II, SHORT 10MM
• 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: 9289931
• MDR Text Key: 165952425
• Report Number: 1220246-2019-01405
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004283
• UDI-Public: 00888867004283
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 10MM
• Device Catalogue Number: AR-1204AS-100
• Device Lot Number: 819884932
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 84