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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4 INCH REAMER WITH JACOBS CHUCK; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO 1/4 INCH REAMER WITH JACOBS CHUCK; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4103231000
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2015
Event Type  malfunction  
Event Description
It was reported that during equipment cleaning by the customer at the user facility, the attachment leaked oil.As this event occurred during cleaning at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event Description
It was reported that during equipment cleaning by the customer at the user facility that the attachment leaked oil.As this event occurred during cleaning at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis is in progress.
 
Manufacturer Narrative
The reported event, attachment is leaking oil, was confirmed.Device was placed in parts retention.
 
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Brand Name
1/4 INCH REAMER WITH JACOBS CHUCK
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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 Key4501276
MDR Text Key5337480
Report Number0001811755-2015-00424
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972367
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 01/13/2015
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 Number4103231000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/02/2015
Initial Date FDA Received02/10/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2014
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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