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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 Problems Unintended Power Up (1162); Device Remains Activated (1525)
Patient Problem No Patient Involvement (2645)
Event Date 08/25/2016
Event Type  malfunction  
Event Description
During functional testing by a service technician at the manufacturer facility, it was found that the handpiece changed direction and would not go into the safe position. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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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 Key5946146
MDR Text Key54557514
Report Number0001811755-2016-02196
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 08/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6203000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2011
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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