MAUDE Adverse Event Report: Medtronic Xomed Inc. IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	1899200
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction

• Brand Name: IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5
• 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 ; +1(763)526-5677
• MDR Report Key: 50069168
• Report Number: 1045254-2026-01057
• Device Sequence Number: 10207130
• Product Code: ERL
• UDI-Device Identifier: 00643169588127
• UDI-Public: (01)00643169588127(11)221219
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 1899200
• Device Catalogue Number: 1899200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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