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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5/32IN INCH DRILL WITH KEY; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO 5/32IN INCH DRILL WITH KEY; ARTHROSCOPE Back to Search Results
Model Number 4100132000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/18/2019
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
5/32IN INCH DRILL WITH KEY
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9437999
Report Number0001811755-2019-03985
Device Sequence Number4202249
Product Code HRX
UDI-Device Identifier04546540068187
UDI-Public04546540068187
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K943323
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) 10/27/2020
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 Number4100132000
Device Catalogue Number4100132000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/18/2019
Supplement Date Received by Manufacturer10/26/2020
Initial Report FDA Received Date12/09/2019
Supplement Report FDA Received Date10/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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