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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; BONE CUTTING INSTRUMENT AND ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; BONE CUTTING INSTRUMENT AND ACCESSORIES Back to Search Results
Catalog Number 5100088000
Device Problem Unintended Power Up (1162)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2014
Event Type  malfunction  
Event Description
It was reported during a procedure, the tps micro driver was running in safe mode.The device also would not go in the correct intended direction.No medical intervention and no adverse consequences were reported with this event.The case was completed with the same device without any delay.
 
Event Description
It was reported during a procedure, the tps micro driver was running in safe mode.The device also would not go in the correct intended direction.No medical intervention and no adverse consequences were reported with this event.The case was completed with the same device without any delay.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
Manufacturer Narrative
Upon evaluation a damaged pcb was discovered, which can cause or contribute to the reported event.
 
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Brand Name
TPS MICRO DRIVER
Type of Device
BONE CUTTING INSTRUMENT AND ACCESSORIES
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 Key4242486
MDR Text Key5068709
Report Number0001811755-2014-04032
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943540
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 10/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100088000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/1999
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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