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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 12MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
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STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 12MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) Back to Search Results
Catalog Number 5407FA1000
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2016
Event Type  malfunction  
Event Description
It was reported while in sterile processing at the user facility, the footed attachment was found to be bent at the footplate.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
FOOTED ATTACHMENT 12MM
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
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 Key5983671
MDR Text Key55824906
Report Number0001811755-2016-02430
Device Sequence Number1
Product Code HBE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/01/2016
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 Number5407FA1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2016
Initial Date Manufacturer Received 09/01/2016
Initial Date FDA Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2016
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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