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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE RECIP SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO CORE RECIP SAW; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400037000
Medical Device Problem Code Unintended Power Up (1162)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/18/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device unintentionally activated during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device unintentionally activated during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Correction: d10, h3.Additional info h6.
 
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Brand Name
CORE RECIP SAW
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 Key10043307
Report Number0001811755-2020-01280
Device Sequence Number11403384
Product Code ERL
UDI-Device Identifier04546540401960
UDI-Public04546540401960
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 09/11/2020
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 Number5400037000
Device Catalogue Number5400037000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 04/18/2020
Supplement Date Received by Manufacturer09/09/2020
Initial Report FDA Received Date05/11/2020
Supplement Report FDA Received Date09/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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