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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYNTHES DRILL; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO SYNTHES DRILL; ARTHROSCOPE Back to Search Results
Catalog Number 4100110000
Device Problem Unstable (1667)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2015
Event Type  malfunction  
Event Description
It was reported that during an ap spinal fusion procedure at the user facility the device was wobbling.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
 
Manufacturer Narrative
The reported failure could not be duplicated and no components were identified which would have likely caused or contributed to the reported failure.The device is not repairable and will not be returned to the user facility.
 
Event Description
It was reported that during an ap spinal fusion procedure at the user facility the device was wobbling.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
 
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Brand Name
SYNTHES DRILL
Type of Device
ARTHROSCOPE
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 Key5250403
MDR Text Key32132786
Report Number0001811755-2015-04319
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
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 11/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4100110000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2014
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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