MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400110000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device was overheating during testing at the user facility.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The customer reported that the device was overheating during testing at the user facility.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
The reported event of the device heating up was not duplicated, as it was found to be seized during testing.Although disassembly findings were not provided, it is likely that due to the age of the device, and based on a review of similar complaints, the reported overheating and observed loss of function were both caused by internal corrosion.

• Brand Name: CORE U-HT DRILL
• 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: 8199137
• Report Number: 0001811755-2018-02897
• Device Sequence Number: 2081874
• Product Code: ERL
• UDI-Device Identifier: 04546540401991
• UDI-Public: 04546540401991
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• 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,Followup
• Report Date (Section B): 03/19/2019

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: 5400110000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1