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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO D" ATTACHMENT"; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO D" ATTACHMENT"; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400210056
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/20/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer sales representative reported that the device was overheating during testing at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
The reported heat symptom could not be confirmed, as the device was not returned for evaluation.Likely causes include worn or damaged bearings.
 
Event or Problem Description
The manufacturer sales representative reported that the device was overheating during testing at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
PD SERIES MAESTRO D" ATTACHMENT"
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 Key8175152
Report Number0001811755-2018-02800
Device Sequence Number1706187
Product Code ERL
UDI-Device Identifier07613153014010
UDI-Public07613153014010
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
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) 04/11/2019
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 Other
Device Catalogue Number5400210056
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/20/2018
Supplement Date Received by Manufacturer11/20/2018
Initial Report FDA Received Date12/18/2018
Supplement Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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