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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYNTHES REAMER; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO SYNTHES REAMER; ARTHROSCOPE Back to Search Results
Catalog Number 4100210000
Device Problem Unstable (1667)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2015
Event Type  malfunction  
Event Description
It was reported that during installation by the customer at the user facility, the synthes reamer wobbled when rotated.As this event occurred during installation at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Customer refuses to return the device.
 
Event Description
It was reported that during installation by the customer at the user facility, the synthes reamer wobbled when rotated.As this event occurred during installation at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
SYNTHES REAMER
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 Key4553484
MDR Text Key5528266
Report Number0001811755-2015-00673
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4100210000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2013
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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