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

Catalog Number	5100010470
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device overheated during testing conducted by a manufacturer field service technician at the user facility.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.

• Brand Name: U SERIES ELITE STRAIGHT LONG 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: 8066531
• Report Number: 0001811755-2018-02464
• Device Sequence Number: 11251007
• Product Code: ERL
• UDI-Device Identifier: 04546540348432
• UDI-Public: 04546540348432
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: No Information
• Device Catalogue Number: 5100010470
• Device Lot Number: 15189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1