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

Catalog Number AR-1204AF-100

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth) 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 discarded 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.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending 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.If additional relevant information is received, a follow-up report will be submitted.Device reported to have been discarded.

Event Description

It was reported that during a left acl reconstruction procedure, the surgeon was using a 10.0mm flipcutter ii.While drilling, the blade broke off of the flipcutter.The blade was retrieved with graspers and both the tip, and the flipcutter were discarded.A second 10.0 flipcutter ii of the same lot (lot: 629368129) was opened and used.This time, while the surgeon was drilling, he heard a sound and began to retract the flipcutter.As he was pulling out of the sleeve, he felt some slight resistance but didn't notice anything unusual with the device.The case was completed and the flipcutter was discarded.After the case, the surgeon ordered an x-ray to see the tunnel and it was then that he noticed a piece of the blade was lodged in the knotch of the patient's knee.

• Brand Name: 10.0 MM FLIP CUTTER II
• Type of Device: INSTURMENT, 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: 6511031
• MDR Text Key: 73363627
• Report Number: 1220246-2017-00140
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 629368129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Patient Age: 40 YR
• Patient Weight: 82