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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 Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 07/29/2015
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 runs on own when the battery was inserted.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
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 Key5031047
MDR Text Key24057268
Report Number0001811755-2015-03124
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
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2015
Date Manufacturer Received07/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2008
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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