MAUDE Adverse Event Report: ARTHREX, INC. 10.0 MM FLIP CUTTER II; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-1204AF-100

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2016

Event Type  Injury  

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 requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.If additional relevant information is received, a follow-up report will be submitted.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging, excessive bending/drilling forces being applied during use.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.Device requested but not yet received.

Event Description

It was reported that an ar-1204af-100, 10mm flipcutter ii, was being used in an acl reconstruction procedure.While drilling the tibial socket with the flipcutter, it broke.The broken piece was not able to be retrieved from the patient.The procedure was completed successfully.Patient: female, bone quality: average.

Manufacturer Narrative

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.This is a follow-up submission due to device evaluation.Complaint confirmed.The device met all material specification as received.The evaluation revealed that the distal tip of the inner rod was severely twisted, and one of the tangs was broken off.In addition, the cutter tip and pins broke away from the inner rod and the actuator tube.The remnants of the torn off pieces were not returned.Furthermore, circular metal gouges were observed around the o.D of the actuator tube, and broken laser weld beam was observed between the actuator tube and inner rod.Further investigation revealed bent inner rod and actuator tube.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging, excessive bending/drilling forces being applied during use.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.

Event Description

It was reported that an ar-1204af-100, 10mm flipcutter ii, was being used in an acl reconstruction procedure.While drilling the tibial socket with the flipcutter, it broke.The broken piece was not able to be retrieved from the patient.The procedure was completed successfully.Patient: female, bone quality: average.

• Brand Name: 10.0 MM FLIP CUTTER II
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6180329
• MDR Text Key: 62543998
• Report Number: 1220246-2016-00584
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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: 07/01/2020
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 521657680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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