MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	15BA40D
Medical Device Problem Codes	Fracture (1260); Vibration (1674); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: em200, serial/lot #: (b)(6), udi#: (b)(4) ; product id: as15, serial/lot #: (b)(6), udi#: (b)(4) h3: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.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 lumbar discectomy surgery the surgeon was using motor along with attachment and tool/burr.When surgeon began to drill very slowly and only used for approximately 10 second, it was vibrating, making abnormal noises and the head of the tool/bur snapped off.It was reported that there was no patient impact and the procedure was completed with backup product.
Additional Manufacturer Narrative
H3: product analysis: product:15ba40d, item:10, lotno: h6027284 evaluation of the device determined that tool was received used, the head is heavily coated in debris.The stem was broken just below the head.Markings on the stem at the approximate bearing locations indicate the tool was used in an attachment with worn bearings and may not have been adequately supported.The suspected root cause is due to inadequate irrigation was used with this tool, which allowed the diamond head to become caked in debris.When the user applied more pressure to compensate the tool fractured.Product id: as15, serial/lot #: (b)(6), udi#: (b)(4) device was returned and the evaluation anticipated but not yet begun.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.
Additional Manufacturer Narrative
H3: product analysis: product: em200, serial/lot #: (b)(6).Evaluation could not reproduce the reported malfunction of vibrating and abnormal noises and the temperature test was within specification at 101°f.However it was noted that the motor fails the hipot test immediately.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 lumbar discectomy surgery the surgeon was using motor along with attachment and tool/burr.When surgeon began to drill very slowly and only used for approximately 10 second, it was vibrating, making abnormal noises and the head of the tool/bur snapped off.It was reported that there was no patient impact and the procedure was completed with backup product.On follow up it was reported that there was no malfunction with the device attachment.

• Brand Name: MIDAS REX LEGEND
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22042029
• Report Number: 1625507-2025-01595
• Device Sequence Number: 9095627
• Product Code: HBE
• UDI-Device Identifier: 00763000061463
• UDI-Public: (01)00763000061463(17)300310(10)H6027284(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K020069
• 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,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15BA40D
• Device Catalogue Number: 15BA40D
• Device Lot Number: H6027284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 09/26/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/17/2025; 10/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 90 KG