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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4208000000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 02/24/2014
Event Type  malfunction  
Event Description
It was reported that the system 5 sagittal saw was leaking an unknown substance during a procedure.The case was completed successfully without a clinically significant delay.It was reported that a culture was taken of the substance.It is unknown from what source the culture was taken.Patient involvement and adverse consequences are unknown.The user facility was not able to provide any further information regarding the reported event.
 
Event Description
It was reported that the system 5 sagittal saw was leaking an unknown substance during a procedure.The case was completed successfully without a clinically significant delay.It was reported that a culture was taken of the substance.It is unknown from what source the culture was taken.Patient involvement and adverse consequences are unknown.The user facility was not able to provide any further information regarding the reported event.
 
Manufacturer Narrative
The reported event, black fluid coming out of the blade mount, was duplicated.The service technician confirmed through inspection that a black substance was present on the handpiece a sample was taken and the handpiece was functionally inspected.It is possible that fluid from non-recommended cleaning procedures or exposure to a non-contained fluid got onto the handpiece.
 
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Brand Name
SYSTEM 5 SAGITTAL SAW
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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 Key3682286
MDR Text Key4300071
Report Number0001811755-2014-00901
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4208000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/14/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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