MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO U SERIES ELITE LONG ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5100010472
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that the device was overheating during a procedure.The procedure was completed successfully with no delay, medical intervention, or adverse consequences.

• Brand Name: U SERIES ELITE LONG ANGLED ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11340007
• Report Number: 0001811755-2021-00606
• Device Sequence Number: 17030537
• Product Code: ERL
• UDI-Device Identifier: 04546540348449
• UDI-Public: 04546540348449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 5100010472
• Device Catalogue Number: 5100010472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1