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

Model Number 9733734

Device Problem Material Fragmentation (1261)

Patient Problems Muscle Weakness (1967); Spinal Cord Injury (2432)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

(b)(6) 2023 mpxr 1096344 (rep, hcp): medtronic received information regarding an imaging system being used during a sacroiliac and t horacolumbar procedure.It was reported that the blue handle became disengaged/malfunctioned from the awl tip tap causing the patient a spinal cord injury.The surgeon, doesn t believe this to be true.Dr.(b)(6) believes the scrub tech never correctly attached the handle to the awl tip tap which caused the instrument to slide off the handle when he introduced to the spine.There is no allegation of the purple instrument tracker as it was simply attached to the awl tip tap.Dr.(b)(6) had 2 screws in before this incident using these same instruments with no issue.After the incident, the scrub tech that alleged the malfunction was given a break and was replaced by another scrub tech for the remainder of the case.They continued to use the same instruments for 6 more screws with no issue.Immediately after the case, the hospital administration wanted me to show them how the instrumentation connects together.The medtronic representative (rep) put on gloves and showed them how to connect the instrument.In the rep's opinion the connection worked perfectly fine.The rep connected and disconnected the instruments several times, no failure.The rep tried to pull the instruments apart, no failure.The rep held the blue handle and in a throwing motion trying to get the handle to disengage, no failure.The administration felt at the time that the instrument was in perfect working order and this was a case of a scrub tech not correctly putting together a instrument and checking it before handing it to the surgeon.The patient was left with sensory issues in his left foot and weakness in both legs.The patient was still in the hospital and was going to need physical therapy.

• Brand Name: NAVLOCK
• Type of Device: 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 ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17860393
• MDR Text Key: 324792470
• Report Number: 1723170-2023-01859
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023

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?: No
• Device Model Number: 9733734
• Device Catalogue Number: 9733734
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male