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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO ANGLED MEDIUM M" ATTACHMENT"; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO ANGLED MEDIUM M" ATTACHMENT"; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400210052
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/16/2019
Type of Reportable Event Malfunction
Event or Problem Description
The device overheated during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The device overheated during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
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Brand Name
PD SERIES MAESTRO ANGLED MEDIUM M" 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 Key8362789
Report Number0001811755-2019-00651
Device Sequence Number19409962
Product Code ERL
UDI-Device Identifier04546540555748
UDI-Public04546540555748
Combination Product (Y/N)N
Initial Reporter StateMI
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) 04/02/2019
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 Number5400210052
Device Lot Number16239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Initial Date Received by Manufacturer 02/16/2019
Supplement Date Received by Manufacturer04/01/2019
Initial Report FDA Received Date02/22/2019
Supplement Report FDA Received Date04/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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