MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE, MAESTRO NON-EXHAUSTING FOOTPEDAL; MOTOR, DRILL, PNEUMATIC

Catalog Number	5400207000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
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: 2 events were reported for this quarter.Product return status: 2 devices were received for evaluation.Evaluation status: 2 device evaluations are in progress.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was reportedly leaking.Two events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
Supplemental rationale corrected data: 2 events were previously reported during the reporting quarter; however:  - 2 events were reported in error. - 0 events were reported for this catalog number/device code combination for the reporting quarter.
Event or Problem Description
This report summarizes 0 malfunction events in which the device was reportedly leaking.

• Brand Name: CORE, MAESTRO NON-EXHAUSTING FOOTPEDAL
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7714829
• Report Number: 0001811755-2018-01216
• Device Sequence Number: 10988999
• Product Code: HBB
• UDI-Device Identifier: 07613154284467
• UDI-Public: 07613154284467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: 5400207000
• 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