MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR MR8 ELECTRIC NAVIGATED S8; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number EM800N

Device Problem Communication or Transmission Problem (2896)

Patient Problems Chemical Exposure (2570); Radiation Exposure, Unintended (3164)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.Phone number: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an l3-s1 lumbar revision, accuracy of the mr8 were off by 2-3 mm laterally.It was noted that there was a procedure extension of less than an hour.On follow up, it was confirmed that two spins were completed instead of one which added 25 minutes to the case and navigation was aborted prior to any action being taken to the patient.It was also added that there was a 35-minute added time for anesthesia due to spins not producing a navigable procedure.Also, there was an additional exposure to radiation for the second spin and a required fluoro to complete the procedure.

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

On further follow up, it was reported that the patient had no further issues post-surgery.

• Brand Name: MOTOR MR8 ELECTRIC NAVIGATED S8
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 10292487
• MDR Text Key: 199659274
• Report Number: 1625507-2020-00094
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K183644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EM800N
• Device Catalogue Number: EM800N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR