MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PAK NEEDLE KIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9733498
Medical Device Problem Codes	Imprecision (1307); Material Deformation (2976)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Tissue Damage (2104)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing date was unavailable at the time of filing.No parts have been returned to the manufacturer for analysis.Part not returned.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during the navigate task of a sacroiliac and thoracolumbar procedure, there was an alleged inaccuracy due to a damaged navigated pedicle access needle (pac).The navigated pac needle was used for a l2-l4 posterior fixation "mis voyager procedure".The pac needle registered using a passive spine frame.The pac needle was used to find the appropriate guidewire position.After insertion of all 6 guidewires the navigated cannulated tab driver was used.Having the guidewires in place and following the acquired path with the navigated tab driver it was alleged that the path was 2mm off the actual target path.After eliminating possible errors - the nav tab and nav driver showed the same path - a new pac needle was used.That showed that the first pac needle was faulty.The site examined the faulty pac needle and it could be seen that the cannula was siting loosely in the handle - which explained why the surgeon was able to register the pac needle - not putting pressure on it.However as soon as the pac needle was within tissue the surgeon was putting pressure on it and therefore showed a different path on the navigation system than its actual path.This incident added approx 2 hours to hour case, which normally would have only taken 1.5 hours due to the fact that the surgeon had to re-position its guidewires and two already inserted screws.The final result was good, there was no reported impact on patient outcome.

• Brand Name: PAK NEEDLE KIT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7851626
• Report Number: 1723170-2018-04421
• Device Sequence Number: 11154983
• Product Code: OLO
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9733498
• Device Lot Number: 180508D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR