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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SABO SAGITTAL SAW ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO SABO SAGITTAL SAW ARTHROSCOPE Back to Search Results
Catalog Number 4300034000
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 09/03/2016
Event Type  malfunction  
Event Description
It was reported that during routine testing conducted by a manufacturer field service technician at the user facility the handpiece would not go into safe mode. This could cause an event of unintentional activation. As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
This reported event was included in manufacturer report number 0001811755-2017-00191.
 
Event Description
It was reported that during routine testing conducted by a manufacturer field service technician at the user facility the handpiece would not go into safe mode. This could cause an event of unintentional activation. As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand NameSABO SAGITTAL SAW
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5983104
MDR Text Key55806203
Report Number0001811755-2016-02414
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 05/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4300034000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2010
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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