MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number FLIPCUTTER II, SHORT 9MM

Device Problems Material Fragmentation (1261); Use of Device Problem (1670); Dull, Blunt (2407)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/01/2020

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 that the ar-1204as-90 flipcutter ii (short) malfunctioned during an acl reconstruction.The flipcutter was making a squealing noise as the surgeon ran the drill, so maybe the blade was a little dull to begin with or there was some disruption inside the shaft.The device did not flip back from the 90 degree position after retro-drilling the tunnel in the femur.This severely complicated the case as the surgeon spent nearly an hour fiddling around with it.Small probes/needles/etc.Were used to try to poke out any bone debris.The doctor had to slightly change their technique as a result, since they had to manually correct this problem.Eventually the surgeon was able to pry the blade out and essentially break it in the joint using a grasper.There was no flipping this blade back to the original position.It was simply too stuck, and the inner/outer sheaths also seemed disconnected.Nothing substantial was left inside the patient.However, there were some metal shavings.The surgeon was able to retrieve most of these metal flakes, but there may still be some in there.The surgeon also had to dissect deeper, as they needed to determine if the lateral femoral cortex was compromised.The rep stated the bone was ok.

Manufacturer Narrative

Complaint confirmed, the device was returned with a detached, damaged and dented cutter tip.The distal end of the actuator tube and inner shaft were twisted and damaged and the actuator shaft was detached from the hub.Likely causes of the event include mechanical damage to device such as hitting the device with another device or object, prying/leveraging or excessive bending forces applied during use.

• Brand Name: FLIPCUTTER II, SHORT 9MM
• 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: 10701225
• MDR Text Key: 212081687
• Report Number: 1220246-2020-02242
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004436
• UDI-Public: 00888867004436
• 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: 10/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: FLIPCUTTER II, SHORT 9MM
• Device Catalogue Number: AR-1204AS-90
• Device Lot Number: 808882232
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other