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

Model Number 9734239

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device lot number and udi number are unavailable. Initial reporter information unavailable at the time of filing. No parts have been returned to the manufacturer for analysis. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the instrument was broken during the sterilization process. There was no patient present when this issue was observed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the tap was bent and was attached to a navlock when the issue occurred.

• Brand Name: NAV 5.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8204830
• MDR Text Key: 131720980
• Report Number: 1723170-2018-06509
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9734239
• Device Catalogue Number: 9734239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse