MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SD/PD SERIES XL ELITE SABER ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5100120480S1
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device overheated during testing at the user facility.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.

• Brand Name: SD/PD SERIES XL ELITE SABER 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: 8478729
• Report Number: 0001811755-2019-01078
• Device Sequence Number: 19098293
• Product Code: ERL
• UDI-Device Identifier: 07613154610518
• UDI-Public: 07613154610518
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/03/2019

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 Catalogue Number: 5100120480S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1