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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" INCH KEYLESS DRILL CHUCK; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO 1/4" INCH KEYLESS DRILL CHUCK; ARTHROSCOPE Back to Search Results
Model Number 4100133000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/09/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had a component missing during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device not returned.
 
Event or Problem Description
The user facility reported that the device had a component missing 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
1/4" INCH KEYLESS DRILL CHUCK
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8836746
Report Number0001811755-2019-02584
Device Sequence Number13970686
Product Code HRX
UDI-Device Identifier04546540377999
UDI-Public04546540377999
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K112593
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) 03/30/2020
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 Number4100133000
Device Catalogue Number4100133000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/09/2019
Supplement Date Received by Manufacturer07/09/2019
Initial Report FDA Received Date07/29/2019
Supplement Report FDA Received Date03/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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