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

Model Number	15BA60D
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Repair request initiated for device with the report of detachment of component.No patient impact reported.Repair is being escalated to product event due to reason for the return.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: aa15, serial/lot#: (b)(6), udi#: (b)(4), product analysis for product id: 1847b06ldm, no conclusion can be drawn.Device evaluation anticipated, but not yet begun.Product id: aa15, serial/lot#: (b)(6): evaluation determined that detached bearing internal tube.The likely cause of failure is corrosion.It was also noted broken tool stuck in attachment, and several parts inside are corroded.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 :it was noted the broken tool was stuck in the attachment, and several parts inside are corroded.Service and repair confirmed that the tool was scrapped.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
Repair request initiated for device with the report of detachment of component.No patient impact reported.Repair is being escalated to product event due to tool broke was stuck in attachment.
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that the tool was broken.The likely cause of failur is identified as the tool was used in an attachment with failed bearings.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.

• 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: 21784457
• Report Number: 1625507-2025-01261
• Device Sequence Number: 18315881
• Product Code: HBE
• UDI-Device Identifier: 00763000453459
• UDI-Public: 00763000453459
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/25/2025

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: 15BA60D
• Device Catalogue Number: 15BA60D
• Device Lot Number: 0229264296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/24/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sex: Unknown