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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7205000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2016
Event Type  malfunction  
Event Description
It was reported that during testing at the manufacturer facility, the handpiece had run-on. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event was duplicated. A service technician functionally evaluated the device and found that the trigger would stick in the reverse position causing run-on. The service technician found contamination on the trigger assembly. Preventative maintenance was performed. Based on a review of risk documentation, contaminates can cause run-on in the trigger area. The event did not involve a product problem indicating a non-conformity or unanticipated hazard. No further action is required at this time.
 
Event Description
It was reported that during testing at the manufacturer facility, the handpiece had run-on. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand NameSYSTEM 7 DUAL TRIGGER ROTARY
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 Key5833532
MDR Text Key50755159
Report Number0001811755-2016-01630
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXAMPT
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 07/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7205000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2012
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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