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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE, MAESTRO DRILL WITH HANDSWITCH; MOTOR, DRILL, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO CORE, MAESTRO DRILL WITH HANDSWITCH; MOTOR, DRILL, PNEUMATIC Back to Search Results
Model Number 5400201000
Medical Device Problem Code Fail-Safe Problem (2936)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/30/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received.Event confirmation status: 2 reported events were confirmed.Evaluation results: 2 devices were found to be affected by a loose handswitch.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 2 malfunction events in which the device experienced a fail-safe problem that could result in unintended activation.2 events had no patient involvement; no patient impact.
 
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Brand Name
CORE, MAESTRO DRILL WITH HANDSWITCH
Common Device Name
MOTOR, DRILL, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10008377
Report Number0001811755-2020-01219
Device Sequence Number2546791
Product Code HBB
UDI-Device Identifier04546540503947
UDI-Public04546540503947
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/29/2020
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 Model Number5400201000
Device Catalogue Number5400201000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date04/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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