MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR LEGEND EHS STYLUS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number EM200

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Chemical Exposure (2570)

Event Date 04/30/2021

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 that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.We will continue to track and trend this complaint type.Information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a surgical procedure, the motor overheated and showed error 15 on ipc.This motor was used along with a 10ba20d tool and ava10 attachment.It was also reported that there was a 120-minute procedure delay and the procedure was completed using a backup device.On follow-up, it was reported that the patient had a prolonged exposure to anesthesia since they have to perform the procedure with a surgical tool and resect the bone one clip at a time.It was also reported that the patient had no further issues post-surgery and there was no issue with the tool and attachment and it will not be returned for evaluation.

Manufacturer Narrative

No conclusion can be drawn.Evaluation could not be performed because d-ring sticking/stuck.It was noted that there was internal corrosion.It was also noted that the shaft was corroded.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.We will continue to track and trend this complaint type.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 LEGEND EHS STYLUS
• 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: 12147160
• MDR Text Key: 262267039
• Report Number: 1625507-2021-00241
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00763000096649
• UDI-Public: 00763000096649
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K012456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EM200
• Device Catalogue Number: EM200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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
• Treatment: 10BA20D (L/N: UNKNOWN) AND AVA10 (S/N: (B)(6))
• Patient Outcome(s): Other