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

Model Number	1845010
Medical Device Problem Codes	Vibration (1674); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
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 model number: 1845020, product description: attachment 1845020 indigo otol angled, serial/lot number: (b)(6)/210474943, udi#: (b)(4), product model number: 1845000, product description: drill 1845000 indigo high speed otologic, serial/lot number: (b)(6)/208048681, ubd: , udi#: (b)(4).Annex g code for angled indigo attachment is g04130.Annex g code for indigo handpiece is g04063.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 use, the indigo attachment was not held securely and was vibrating.There was no patient impact.
Additional Manufacturer Narrative
H3: it was found in the analysis that the bearings were worn laser markings were faded and spring was worn.H6: fdm b21, fdr c21, img g04130 and fdc d16 codes no longer apply.Product model number: 1845020, product description: attachment 1845020 indigo otol angled, serial/lot number: p06245364/210474943 - it was found in the analysis that the distal bearing was detached.The laser markings were faded.H6:fdm b01, fdr c0601, c07 img g04011,g02004,g04118 and fdc d02 product model number: 1845000, product description: drill 1845000 indigo high speed otologic, serial/lot number : 13i3045/208048681 - it was found in the analysis that the bearing and spring were worn.The laser markings were faded.H6:fdm b01, fdr c0601, c070602 img g04011,g04080 and fdc d02 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: 19936165
• Report Number: 1625507-2024-00260
• Device Sequence Number: 7319155
• Product Code: HBE
• UDI-Device Identifier: 00613994933706
• UDI-Public: 00613994933706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081475
• 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): 10/09/2024

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: 1845010
• Device Catalogue Number: 1845010
• Device Lot Number: 212016152
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Sex: Unknown