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

Catalog Number 9734298

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.On (b)(4) 2016 - a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested for suspect tap 4.5.Medtronic investigation of returned suspect device finds that, as reported, the tip of the instrument is slightly bent.The tip is also blocked with bony material.Physical damage - bent instrument tip hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative received a report from a site that, while in a spine procedure, they discovered a 4.5 solera tap that was visibly bent near the tip.The instrument passed verification, however, when the tap was rotated by the site surgical technician they noticed it was visibly bent.This damage was noted prior to the tap being used in the procedure.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5480600
• MDR Text Key: 39756174
• Report Number: 1723170-2016-00291
• 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
• Type of Report: Initial
• Report Date: 03/04/2016

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: 9734298
• Device Lot Number: 121012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2012
• 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