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); Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2019

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 that the ar-1204as-90, flipcutter ii was drilled into the joint through the femur.Flipcutter was flipped into what was thought to be the reaming position, and the tunnel was reamed for approximately 10mm before metal pieces were seen at the aperture of the tunnel.Metal pieces were retrieved as best as possible.However, one small piece was lost and could not be retrieved at the back of the knee.Flipcutter was pulled out of the femoral tunnel and socket was re-drilled with a new flipcutter.Tibial side was drilled without incident.It was reported that a second surgery is not necessary.Additional information received on 01/07/2020: the procedure taking place was an arthroscopic acl reconstruction.The retrieved metal pieces were removed by using a grasper, and no unplanned incisions were made.The complaint device will be returning to arthrex for evaluation.

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 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: 9607410
• MDR Text Key: 189981290
• Report Number: 1220246-2020-01583
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLIPCUTTER II, SHORT 9MM
• Device Catalogue Number: AR-1204AS-90
• Device Lot Number: 911292935
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other