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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM); ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM); ARTHROSCOPE Back to Search Results
Catalog Number 4100125000
Device Problem Metal Shedding Debris (1804)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2016
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility, the device had metal shavings coming out of it.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
PIN COLLET (2.0-3.2MM)
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 Key5914889
MDR Text Key53501360
Report Number0001811755-2016-02044
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/03/2016
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 Other
Device Catalogue Number4100125000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2016
Initial Date Manufacturer Received 08/03/2016
Initial Date FDA Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2013
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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