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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 Patient Involvement (2645)
Event Date 02/10/2015
Event Type  malfunction  
Event Description
It was reported that the handpiece is stuck in on position during inspection before the procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.After receiving at the manufacturer facility it was found that the handpiece was running without pressing the trigger.
 
Event Description
It was reported that the handpiece is stuck in on position during inspection before the procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.After receiving at the manufacturer facility it was found that the handpiece was running without pressing the trigger.
 
Manufacturer Narrative
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis is in progress.
 
Manufacturer Narrative
Device was repaired and returned after passing the final inspection.
 
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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 Key4608238
MDR Text Key5656177
Report Number0001811755-2015-00966
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 02/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2015
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 Manufacturer02/23/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2005
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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