MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734239

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative inspected the navigation system onsite and replaced the taps.The system was returned to service.Device manufacturing date is dependent on lot number, therefore, unavailable at this time.The suspect part has not been returned to the manufacturer for evaluation.Reference mdr 1723170-2018-00181 for the other tap used in this procedure.

Event Description

A medtronic representative reported that while in a sacroiliac and thoracolumbar procedure the k wire was getting 'stuck' in the taps.One surgeon was holding the k wire while another was manipulating the tap to get it off around the k wire and was successful.The site is proceeding with universal drill guide (udg) to create a hole and a non-medtronic tap to continue without issue.There was a reported delay to the procedure of less than 10 minutes due to this issue and no impact on the patient outcome.

Manufacturer Narrative

Fda codes were updated to reflect current coding guidelines.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAV 5.5MM 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: stephanie riley ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7183035
• MDR Text Key: 97090114
• Report Number: 1723170-2018-00193
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734239
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 05/03/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 82