MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND; MOTOR, DRILL, ELECTRIC

Model Number	EM100-A
Medical Device Problem Codes	Loss of Power (1475); Dull, Blunt (2407); Noise, Audible (3273)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Oversedation (1990); Chemical Exposure (2570)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: f2/8ta23 (lot number-unknown) h3: product analysis: no evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the surgery of the endoscopic combined with microscopic resection of a huge space-occupying lesion in the left frontal lobe, internal decompression, and dura mater repair under general anesthesia.When the surgeon was opening the skull, he found that the sound of the medtronic motor was different from usual, and the drill bit and milling cutter could not work on the skull.He immediately opened the bojin micro-medical electric saw drill as a replacement.When the bojin micro-medical electric saw drill was used, it was found that the drill was unresponsive and the milling cutter speed was too low to be used.Immediately opened the hand drill and wire saw as a replacement, and the surgery could continue.This made prolonged the surgery time and anesthesia time, affected the surgeon's operations, increased the amount of bleeding, and affected the patient's postoperative outcome.
Additional Manufacturer Narrative
H3:product analysis: no evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: f2/8ta23(lot number-h5955837) product analysis: no conclusion can be drawn.No evaluation was performed, as the device was device discarded by customer.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the surgery of the endoscopic combined with microscopic resection of a huge space-occupying lesion in the left frontal lobe, internal decompression, and dura mater repair under general anesthesia.When the surgeon was opening the skull, he found that the sound of the medtronic motor was different from usual, and the drill bit and milling cutter could not work on the skull.He immediately opened the bojin micro-medical electric saw drill as a replacement.When the bojin micro-medical electric saw drill was used, it was found that the drill was unresponsive and the milling cutter speed was too low to be used.Immediately opened the hand drill and wire saw as a replacement, and the surgery could continue.This made prolonged the surgery time and anesthesia time, affected the surgeon's operations, increased the amount of bleeding, and affected the patient's postoperative outcome.On additional follow up the surgery extended up to one hour and there was no blood transfusion required during or after surgery.The estimated blood loss for the surgery was not known and the patient did not have any ischemic injury from blood loss.The patient current status is good condition.

• Brand Name: MIDAS REX LEGEND
• Common Device Name: MOTOR, DRILL, ELECTRIC
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21863448
• Report Number: 1625507-2025-01462
• Device Sequence Number: 7767921
• Product Code: HBC
• UDI-Device Identifier: 10885074106486
• UDI-Public: 10885074106486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: EM100-A
• Device Catalogue Number: EM100-A
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female