MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE UNIVERSAL DRIVER

Catalog Number	5400099000
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device was running on its own during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CORE UNIVERSAL DRIVER
• Common Device Name: CORE UNIVERSAL DRIVER
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8428053
• Report Number: 0001811755-2019-00842
• Device Sequence Number: 198505
• Product Code: ERL
• UDI-Device Identifier: 04546540401977
• UDI-Public: 04546540401977
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 5400099000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1