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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5100004000
Device Problem Unintended System Motion (1430)
Patient Problem No Patient Involvement (2645)
Event Date 06/16/2014
Event Type  malfunction  
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the tps handpiece cord was causing a handpiece to spontaneously activate.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility, the tps handpiece cord was causing a handpiece to spontaneously activate.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Updated to indicate that the product will not be returned.The device will not be returned; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The device will not be returned by the user facility.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during routine maintenance conducted by a manufacturer field service technician at the user facility the tps handpiece cord was causing a handpiece to spontaneously activate.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
TPS HANDPIECE CORD
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 Key3929069
MDR Text Key4587903
Report Number0001811755-2014-02467
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,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100004000
Device Lot Number11322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2011
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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