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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 Material Twisted/Bent (2981)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/08/2018
Type of Reportable Event Malfunction
Event or Problem Description
The device was found to be bent during service at the manufacturer facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
It was confirmed the duraguard was bent by the service technician through visual inspection.
 
Event or Problem Description
The device was found to be bent during service at the manufacturer 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 Key8033952
Report Number0001811755-2018-02359
Device Sequence Number16509954
Product Code ERL
UDI-Device Identifier07613153014010
UDI-Public07613153014010
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K041754
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) 12/12/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Initial Date Received by Manufacturer 10/08/2018
Supplement Date Received by Manufacturer12/12/2018
Initial Report FDA Received Date11/02/2018
Supplement Report FDA Received Date12/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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