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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORE MOTOR CONTROLLER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORE MOTOR CONTROLLER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400050000
Medical Device Problem Code Unintended Power Up (1162)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/25/2021
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device was running without activation during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device was running without activation during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
CORE MOTOR CONTROLLER
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 Key12033590
Report Number3015967359-2021-01191
Device Sequence Number14553849
Product Code ERL
UDI-Device Identifier07613153011781
UDI-Public07613153011781
Combination Product (Y/N)N
Initial Reporter StateNY
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) 09/21/2021
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 Number5400050000
Device Catalogue Number5400050000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2021
Initial Date Received by Manufacturer 05/25/2021
Supplement Date Received by Manufacturer09/21/2021
Initial Report FDA Received Date06/21/2021
Supplement Report FDA Received Date09/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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