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

Catalog Number 9734238

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

The instruction for use (ifu) which accompanies this device contains cautions and instructions regarding the cleaning of these devices to prevent injury including: "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." patient information was not made available from the site as there was no patient present - the injury was to an employee and request for employee demographic information was declined by the site.Device lot number not available as the site cannot provide the specific device name or part number.Device manufacturing date is dependent on lot number, therefore, unavailable.After reporting the event to a medtronic representative, the site declined to provide any details as to specific information regarding the employee that was alleged to be injured, seriousness of the alleged injury, the specific instrument name or part number, where the suspect instrument is or how it is being handled.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.This device is included in the medical device field correction notification, "potential for user injury ¿ medtronic navigated cannulated taps" (may 2015).The revised instructions for use (ifu) were also provided with the notification.

Event Description

A medtronic representative reported that, while in sterile processing at a site, an employee was injured when using a k-wire to attempt to dislodge debris from inside the tap.Injury occurred during the cleaning and sterilization after a surgery.Seriousness of injury is unknown, size of tap is unknown, and procedure date and surgeon name are also not provided.Sterile processing department is not able to answer which case the taps had been used on.

Manufacturer Narrative

Correction: the size of the tap related to the reported incident was reported to be unknown and attempts to follow-up were unsuccessful.The two possible tap sizes that could have been potentially involved were as follows: nav 5.5mm tap (cannulated), catalog number 9734239.Nav 6.5mm tap (cannulated), catalog number 9734240.The site spd manager declined to provide any additional details about the incident.

• Brand Name: NAV 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 80027-9710 ; 7208902082
• MDR Report Key: 5690169
• MDR Text Key: 46253092
• Report Number: 1723170-2016-00987
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734238
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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