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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 Problems Unintended Power Up (1162); Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 02/03/2015
Event Type  malfunction  
Event Description
It was reported during set up before a procedure at user facility, the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported during set up before a procedure at user facility that the handpiece is overheating and it is running on its own once connected with the battery.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.
 
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 in progress.
 
Manufacturer Narrative
The reported event, handpiece is overheating and runs on its own, was confirmed.Device was repaired and returned to the customer after passing the final inspection.
 
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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 Key4561198
MDR Text Key5475759
Report Number0001811755-2015-00735
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 02/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4205000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/23/2015
Initial Date FDA Received03/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2004
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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