MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PAK 9733498NAV NAVIGATED PEDICLE ACCESS; INSTRUMENT, STEREOTAXIC

Model Number	9733498NAV
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that during procedure 2 needles were damaged.One needle broke inside the patient and pieces had to be removed from inside the pine with difficulty.The patient was required to be converted to an open procedure from a minimally invasive one.A part of the needle was left inside the patient because the surgeon determined that it would cause more harm attempting to retrieve the broken item.The procedure finished successfully.Three needles were used on the case.One broke, one bent and the other worked as intended.
Additional Manufacturer Narrative
Correction: the report source was updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PAK 9733498NAV NAVIGATED PEDICLE ACCESS
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9174895
• Report Number: 1723170-2019-05173
• Device Sequence Number: 2614887
• Product Code: HAW
• UDI-Device Identifier: 00643169345171
• UDI-Public: 00643169345171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: 9733498NAV
• Device Catalogue Number: 9733498NAV
• Device Lot Number: 190126A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: 55 YR