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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; DRIVER, WIRE, AND BONE DRILL,
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STRYKER INSTRUMENTS-KALAMAZOO TPS MICRO DRIVER; DRIVER, WIRE, AND BONE DRILL, Back to Search Results
Catalog Number 5100088000
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2014
Event Type  malfunction  
Event Description
It was reported that the tps micro driver kept rotating after release of the trigger during a procedure.The case was completed successfully without any procedure delay.There was no medical treatment or intervention required as a result of the event and no adverse consequences.
 
Event Description
It was reported that the tps micro driver kept rotating after release of the trigger during a procedure.The case was completed successfully without any procedure delay.There was no medical treatment or intervention required as a result of the event and no adverse consequences.
 
Manufacturer Narrative
Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.
 
Manufacturer Narrative
The reported event was not duplicated; however, corroded electrical sockets were found by the diagnostic engineer during the device inspection.The presence of corroded sockets may cause or contribute to the reported event.
 
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Brand Name
TPS MICRO DRIVER
Type of Device
DRIVER, WIRE, AND BONE DRILL,
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 Key3630769
MDR Text Key3984982
Report Number0001811755-2014-00457
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 01/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100088000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/20/2001
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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