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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PD SERIES MAESTRO STRAIGHT "AM" ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PD SERIES MAESTRO STRAIGHT "AM" ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400210070
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/08/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer field service technician reported that the device overheated while it was being demonstrated at the user facility.There were no adverse consequences related to this event.
 
Event or Problem Description
The manufacturer field service technician reported that the device overheated while it was being demonstrated at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Corrected data: d9, h3.H3 other text : device not returned.
 
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Brand Name
PD SERIES MAESTRO STRAIGHT "AM" ATTACHMENT
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12099733
Report Number3015967359-2021-01303
Device Sequence Number4215440
Product Code ERL
UDI-Device Identifier04546540469236
UDI-Public04546540469236
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
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) 07/30/2021
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 Other
Device Model Number5400210070
Device Catalogue Number5400210070
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/08/2021
Supplement Date Received by Manufacturer07/29/2021
Initial Report FDA Received Date07/01/2021
Supplement Report FDA Received Date07/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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