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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SINGLE TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SINGLE TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 6203000000
Device Problem Unintended Power Up (1162)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2016
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, the handpiece activated on its own without pulling the trigger. No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a surgical procedure at the user facility, the handpiece activated on its own without pulling the trigger. No delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand NameSINGLE TRIGGER ROTARY HANDPIECE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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 Key5956970
MDR Text Key54949371
Report Number0001811755-2016-02263
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6203000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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