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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4203000000
Device Problem Unintended Power Up (1162)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2014
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure conducted at the user facility, the trigger of the device was getting stuck in the on position, a condition which caused the device to run without user activation and then lose power.The procedure was completed successfully using back-up equipment without a clinically significant delay.No medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event was not able to be duplicated by a manufacturer repair technician through functional evaluation.However, upon disassembly, a broken carriage assembly was identified, which can caused or contribute to the reported event.
 
Event Description
It was reported that during a surgical procedure conducted at the user facility, the trigger of the device was getting stuck in the on position, a condition which caused the device to run without user activation and then lose power.The procedure was completed successfully using back-up equipment without a clinically significant delay.No medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
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Brand Name
SYSTEM 5 SINGLE 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 Key4254972
MDR Text Key15345277
Report Number0001811755-2014-04130
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4203000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2003
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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