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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO RIGHT ANGLE ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO RIGHT ANGLE ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400210011
Medical Device Problem Codes Overheating of Device (1437); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device results.
 
Event or Problem Description
The user facility reported that the device overheated.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
PD SERIES MAESTRO RIGHT ANGLE 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 Key10350103
Report Number0001811755-2020-02009
Device Sequence Number2329952
Product Code ERL
UDI-Device Identifier04546540469151
UDI-Public04546540469151
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/27/2021
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 Health Professional
Device Model Number5400210011
Device Catalogue Number5400210011
Device Lot Number19168
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/02/2020
Supplement Date Received by Manufacturer05/27/2021
Initial Report FDA Received Date07/31/2020
Supplement Report FDA Received Date05/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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