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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 Disassembly (1168)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/15/2015
Event Type  Injury  
Event Description
It was reported that in the central sterile department of the user facility after a surgical procedure at the user facility, a screw had fallen out of the device, posing the risk of a small component being lost in a surgical site.The procedure was completed successfully, and there was no surgical delay.The patient was given an x-ray, and no screw was observed.No adverse consequences were reported.
 
Manufacturer Narrative
The service technician observed the decorative screw was missing.
 
Event Description
It was reported that in the central sterile department of the user facility after a surgical procedure at the user facility, a screw had fallen out of the device, posing the risk of a small component being lost in a surgical site.The procedure was completed successfully, and there was no surgical delay.The patient was given an x-ray, and no screw was observed.No adverse consequences were reported.
 
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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 Key5220190
MDR Text Key31009123
Report Number0001811755-2015-04122
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2015
Is this an Adverse Event Report? Yes
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 Manufacturer10/27/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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