MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-1204AS-100

Device Problems Entrapment of Device (1212); Sticking (1597)

Patient Problem No Information (3190)

Event Date 03/26/2014

Event Type  Injury  

Event Description

It was reported that during an acl procedure, the flipcutter was used to create the tunnel in the femur.Surgeon could not get it to un-hinge completely to allow it to pass through the cannula.There was no bone stuck in it.They had to remove the whole cannula with the flipcutter inside of it.The surgeon then changed the technique to an inside out one.Another incision was created to pass tigerstick suture for graft passage to complete the procedure.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed the distal tip area of the actuator is flared, however, the device still actuates.The indentations on the cutter appear to have resulted from removal of the device from the patient.The most likely cause of the flared tip is due to excessive force being applied while reaming, starting the reamer while against the bone or the device coming into contact with another device while spinning.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

• Brand Name: FLIPCUTTER II, SHORT 10MM
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 3772026
• MDR Text Key: 16551569
• Report Number: 1220246-2014-00065
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: AR-1204AS-100
• Device Lot Number: 225737243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other