MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	1898200T
Medical Device Problem Codes	Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 two of the m4 handpieces are not functioning as intended.When the handpieces are connected to the console, one motor is not responsive and the other heats up immediately and cannot be used.There was no patient involved.
Additional Manufacturer Narrative
H6: previously applied code of fdc d16 is no longer applicable.Device return was requested.However, the device was not returned therefore, device analysis was not able to be performed.There was no indication that the event was related to a potential manufacturing issue.Therefore, no device history record (dhr) review was performed.Customer was contacted for additional information to identify the root cause but there was no response received.Hence, identified the suspected likely cause of the event could be anticipated use characteristics.The device has been used for more than a year with no repair.Ifu or product experience suggests that the behavior is typical for the given the circumstances, or the failure occurred over a period of time.There could be a failure or worn out of any components which could have caused the reported issue.Worn or any component failure can also lead to overhearing for the handpiece when operated.The complaint investigation determined that this event had foreseen risk and is included in monitoring, and therefore no further action was required.Common sequences of events and contributing factors that can lead to this event are documented in the risk management file.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 - XPS® STRAIGHTSHOT® M4
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 19903457
• Report Number: 1045254-2024-01189
• Device Sequence Number: 6557205
• Product Code: ERL
• UDI-Device Identifier: 00885074080932
• UDI-Public: 00885074080932
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K041413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 1898200T
• Device Catalogue Number: 1898200T
• Device Lot Number: 206143202
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 11/09/2024
• Initial Report FDA Received Date: 08/04/2024
• Supplement Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 09/13/2012
• 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