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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET; ARTHROSCOPE Back to Search Results
Catalog Number 4100125000
Device Problem Metal Shedding Debris (1804)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2014
Event Type  malfunction  
Event Description
It was reported that after a surgical procedure at the user facility that the device had metal shavings coming out of it.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Evaluation: conclusion: the device has been discarded by the manufacturer.
 
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Brand Name
PIN COLLET
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 Key4390951
MDR Text Key5363511
Report Number0001811755-2015-00039
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
Report Date 12/11/2014
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 Number4100125000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2014
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2012
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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