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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4205000000
Device Problem Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2015
Event Type  malfunction  
Event Description
It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece is running in reverse while the safety switch is on.This event occurred during testing therefore, 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 during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece is running in reverse while the safety switch is on.This event occurred during testing therefore, no associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Device not returned to manufacturer for investigation.Customer has refused to return the device for evaluation.
 
Manufacturer Narrative
The reported event, "the device still runs in reverse while safe is on", was not duplicated and no failures were confirmed as the device was not available for investigation.Device was not returned to the manufacturer facility for evaluation.
 
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Brand Name
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
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 Key4634897
MDR Text Key5747780
Report Number0001811755-2015-01127
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972367
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 02/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4205000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2005
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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