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

Catalog Number	9733498
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This part was discarded by the site and will not be returned to manufacturer for analysis.The site used backup instrument in the kit.No parts have been replaced.No findings possible.Instrument discarded.
Event or Problem Description
A medtronic representative reported that while in a spinal fusion procedure, the instrument broke off in the left l5 pedicle.The surgeon eventually removed the piece of instrument.They confirmed with x-ray that all of the instrument was completely removed from patient.This caused a 45 minute delay in procedure.The surgeon completed the procedure with the use of the navigation system and the backup instrument from the kit.There was no adverse impact to the patient reported.It was reported that the patient's bone was very osteoporotic and more susceptible to the needle becoming stuck.

• 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: 6206475
• Report Number: 1723170-2016-05939
• Device Sequence Number: 873898
• Product Code: OLO
• UDI-Device Identifier: 00643169345171
• UDI-Public: 00643169345171
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/27/2016

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
• Operator of Device: Physician
• Device Expiration Date: 09/24/2018
• Device Catalogue Number: 9733498
• Device Lot Number: 160924A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 86