MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	1845020
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 the intraoperatively, the indigo attachment works by fits and starts.The bur shakes.There was no patient impact.
Additional Manufacturer Narrative
H3:analysis of attachment found corroded bearing inside the tube and worn laser markings.Customer's complaint was confirmed.H6: previously submitted codes fdm b21, fdr c21 and fdc d16 are no longer applicable.Additional code: previously submitted img code g04130 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL
• 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 ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21134601
• Report Number: 1625507-2025-00039
• Device Sequence Number: 7582838
• Product Code: HBE
• UDI-Device Identifier: 00613994933690
• UDI-Public: 00613994933690
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 1845020
• Device Catalogue Number: 1845020
• Device Lot Number: 212151597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2016
• 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
• Patient Sex: Unknown