MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE U-HT DRILL; MOTOR, DRILL, PNEUMATIC

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	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 3 events were reported for this quarter.Product return status: 3 devices were received for evaluation.Evaluation status: 3 device evaluations are in progress.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 3 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 1 reported event was confirmed during testing.- 1 device was found to be affected by a corroded rotor.2 reported events were not confirmed during testing; however: - 2 devices were found to be affected by a corroded rotor.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.

• Brand Name: CORE U-HT DRILL
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8016737
• Report Number: 0001811755-2018-02292
• Device Sequence Number: 11172805
• Product Code: HBB
• UDI-Device Identifier: 04546540401991
• UDI-Public: 04546540401991
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• 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: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/29/2018
• 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