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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 STERNUM SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 STERNUM SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 6207000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2016
Event Type  malfunction  
Event Description
It was reported that during device evaluation conducted at the manufacturer facility the device ran at a high speed. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Device evaluation complete.
 
Event Description
It was reported that during device evaluation conducted at the manufacturer facility the device ran at a high speed. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand NameSYSTEM 6 STERNUM SAW
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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 Key5976328
MDR Text Key55566936
Report Number0001811755-2016-02371
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 07/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6207000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2009
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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