MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NONE

Device Problem Complete Blockage (1094)

Patient Problems Injury (2348); Iatrogenic Source (2498)

Event Date 06/02/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight were not made available from the site.Patient in this event was a site user in central processing, outside of surgery.Return requested for 4.5mm tap (cannulated).No parts have been received by manufacturer for analysis.Note: use of taps in a manner that causes them to be clogged is contradictory to medtronic instructions for use.Medtronic navigation is filing this mdr to ensure visibility to a site user event as a result of a procedure that utilized medtronic navigation's 4.5mm tap (cannulated).Use of taps in a manner that causes them to be clogged is contradictory to medtronic instructions for use.

Event Description

User medwatch 3500a form (b)(4) - user, site central processing, punctured while cleaning a solera tap with a k-wire.On 8/18/2015, pqe received a user medwatch 3500a form from the fda that was submitted by a site risk coordinator.The following are excerpts from the fields on the form: event description: associate in central processing using a wire to break down impacted bone inside a cannulated drill bit (middle and index fingers puncture wound).All other options including flushing of item, brushes and sonic used prior to help aid in the cleaning process.Occasionally wires are used in decontamination to dislodge impacted bones.Puncture wounds assessed by occupational health/walk-in and associate will have requisite blood draws over next 3 months to monitor.Manufacturer had sent an urgent medical device correction notification regarding the cannulated tips and potential for injury which could occur as a result of cleaning the cannulated tips (letter dated a couple of months ago; received by this hospital and disseminated on the same date and injury to technician occurred).Manufacturer's notification cautioned of potential for injury.Incident occured while cleaning a difficult item and the manufacture states there may be a need to clean with wires.Fda safety notification arrived to our risk manager the same day the injury occurred.Sent communication to representative and all staff necessary.Central processing sterilizes instruments post-surgery: after a spinal procedure in which the tap was used to pre-drill into the spine, the device was sent to central processing where the instrument technicians first used nylon brushes and ultrasonic bath then k-wires to dig out impacted bone.During the use with wire, our central processing technician punctured the middle finger with the wire used for reaming, and the index finger with tip of the cannula.Medtronic navigation is filing this mdr to ensure visibility to a site user event as a result of a procedure that utilized medtronic navigation's 4.5mm tap (cannulated).Use of taps in a manner that causes them to be clogged is contradictory to medtronic instructions for use.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

Manufacturer Narrative

The instructions for use which accompany these instruments, contains warnings and instructions regarding the cleaning of these devices to prevent injury: "caution: cannulated taps have the potential to accumulate bone and other tissue in the cannula.Using a cannulated tap without a guide wire can increase the possibility of bone and tissue accumulation.Please use caution when cleaning the cannula because using sharp instruments to remove material from the obstructed cannula may cause injury to areas of the body including the hand.If the obstruction cannot be removed from the cannula, the device is considered to be at the end of its useful life.Dispose of the device according to national regulations." "point of use: [.] cannulated taps have the potential to accumulate bone and other tissue in the cannula.Use without a guide wire can increase this possibility.If the obstruction cannot be removed from the cannula, the device will be considered at the end of its useful life.Dispose of the device according to national regulations.[.]".

Manufacturer Narrative

Correction: information provided that was inadvertently left off initial mdr.(b)(4).

• Brand Name: 4.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027 ; 7208902082
• MDR Report Key: 5083271
• MDR Text Key: 25990646
• Report Number: 1723170-2015-01104
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Followup,Followup,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NONE
• Device Catalogue Number: 9734298
• Device Lot Number: 120416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1847-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR