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

Model Number EM800

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Device Displays Incorrect Message (2591); Physical Resistance/Sticking (4012)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.Other relevant device(s) are: product id: mr8-aa14, serial/lot #: (b)(4).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

It was reported that when drill was connected to an ipc console, attachment and bur were installed and placed on the drapes without being used. it was noticed that the drill had melted the drapes and was touching the patient. the drill was hot enough to leave a burn mark on the patient¿s skin. it was reported that no one was stepping on the pedal at any point and the drill was never used. it was also reported that device gave an error code (15) on the console when they first plugged it in. it was reported that when the drill was plugged back into the console, error 15 code popped up when foot control is depressed and disappeared when the pedal is released. the drill was left plugged in for 5 minutes but could not get the heat up.It was reported that the attachment is removed, the collet is manually locked but the motor would not run and gave error code and the procedure was completed with a back up device.

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 patient got burns on her abdomen or arm, burnt through her gown first, that¿s how physician noticed it.It melted the drape on the patient and went through it and burned the patient.The burn to the patient was 1st degree burn, hence it didn¿t require any treatment.There was no additional treatment needed for the burn.There was erythema on the skin but no excoriation or violation of the skin surface.Burn was a red welt, bandage that has antimicrobial in it was put on the patient.

Manufacturer Narrative

Product analysis for device mr8-aa14: evaluation could not be performed because internal tube was seized.It was noted that there was bent in internal tube bearing.This finding may have contributed to the user's experience.Product analysis for em800: no conclusion can be drawn.Evaluation could not be performed because couldn't able to locate the device /lost.B5: additional information received from duplicate event: it was reported taht the event occured during the operating room team was preparing to turn the patient over, as it was a 360 spine case.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: MOTOR MR8 ELECTRIC
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 16101129
• MDR Text Key: 306680811
• Report Number: 1625507-2023-00005
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00643169912106
• UDI-Public: 00643169912106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EM800
• Device Catalogue Number: EM800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2021
• 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): Other