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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE ARTHROSCOPE Back to Search Results
Catalog Number 4300000000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2018
Event Type  malfunction  
Event Description
It was found the dummy navigation connector was broken and a portion of it missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
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Brand NameCORDLESS DRIVER 3 HANDPIECE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8203047
MDR Text Key131707195
Report Number0001811755-2018-02910
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4300000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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