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

Model Number	1897200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found motor shorted and bearings corroded.Tool cannot be inserted and can't perform pre-temperature test.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via distributor that the handpiece overheated during operation.There is no patient impact.Upon follow up, it was reported that the device overheated in less than a minute.They turned on the power, connected the handpiece to the console, stepped on the pedal, and it got hot during use.There was no delay in the surgical procedure but a back up device was used.

• Brand Name: XPS® HANDPIECE - MAGNUM® II
• 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 13866962
• Report Number: 1045254-2022-00146
• Device Sequence Number: 5371344
• Product Code: ERL
• UDI-Device Identifier: 00643169360846
• UDI-Public: 00643169360846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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: 1897200
• Device Catalogue Number: 1897200
• Device Lot Number: 213033273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2017
• 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