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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 4 events were reported for this quarter.Product return status: 4 devices were received for evaluation.Evaluation status: 1 event was confirmed during testing, - 1 device was found to be affected by friction problem (rotor rub), 3 device evaluations are in progress.Product disposition: the device was repaired and returned to the user facility.Additional information: there were no remedial actions taken on this device.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated; 3 events had no patient involvement; no patient impact; 1 event had no known patient involvement or patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 4 total events were initially reported.3 previously reported events are included in this follow-up record.  product return status 3 devices were received.  evaluation status confirmed 3 reported events were confirmed during testing.- 1 device was found to be affected by rotor rub/damage.- 1 device was found to be affected by damaged rotor assembly.- 1 device was found to be affected by worn rotor stop.  additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.1 event had no known patient involvement or patient impact.

• 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: 7715286
• Report Number: 0001811755-2018-01371
• Device Sequence Number: 13715623
• Product Code: ERL
• UDI-Device Identifier: 04546540401991
• UDI-Public: 04546540401991
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: No Information
• Device Catalogue Number: 5400110000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1