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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOANER TPS MICRODRIVER; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO LOANER TPS MICRODRIVER; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5100088000L
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 11/24/2014
Event Type  malfunction  
Event Description
The loaner tps microdriver was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device was missing a trigger button.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
The loaner tps microdriver was returned to stryker instruments for service.During functional testing by a service technician, it was found that the device was missing a trigger button.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The failure was confirmed by the repair technician through visual inspection.The device was repaired and placed back into stryker stock.
 
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Brand Name
LOANER TPS MICRODRIVER
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
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 Key4349735
MDR Text Key5199739
Report Number0001811755-2014-04615
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 Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100088000L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/1999
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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