MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Codes	Material Integrity Problem (2978); Device Handling Problem (3265)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No parts have been returned to medtronic for analysis.Adverse event problem codes b17, c20, d15 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a procedure.It was reported that the thoracic probe broke while being malleted into the patient¿s pedicle, about 40mm deep.The surgeon was drill drilling around the piece to get it out, but would have drilled out a lot of the pedicle by the time he got it out.The surgeon decided to leave the tip of the probe (approximately 37 mm) in the patient's pedicle, and vertebral body due to suspected more harm than benefit by removing it.Additional information was received.The surgeon drilled around the screw slightly, and tried to pull the broken piece out with a few different instruments, but stopped out of concern that trying to remove it would do more harm than good.The surgeon noted that they put a lot of force on the mallet, and the surgeon noted this, to paraphrase, "that this would not have been a problem on most of his patients, but this patient's bone was very dense".The patient was not able to receive the full planned fusion on one side (lumbar 3 to lumbar 5) since the piece was stuck in the right lumbar 4 pedicle.There was no plan for an additional surgery at that time.This occurred intraoperatively, and during a lumbar 3 to lumbar 5 posterior fusion procedure.There was a surgical delay of 10-20 minutes as the surgeon did not spend too much time trying to free the broken piece.
Additional Manufacturer Narrative
D4) additional information: lot number and unique identifier updated.H4) additional information: updated.H6) additional information: additional fdd code added to reflect event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVLOCK
• Common Device Name: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16506342
• Report Number: 1723170-2023-00351
• Device Sequence Number: 3352433
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: 00763000054205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 201024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 62 KG