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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 Problems Leak/Splash (1354); Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  malfunction  
Event Description
It was reported by the user facility that the attachment was leaking metal shavings.Due to the device being found on a desk with a note, no further information regarding patient involvement, delay, medical intervention, or adverse consequences was provided by the user facility.
 
Manufacturer Narrative
The failure for metal flakes coming from device was confirmed by the technician.No components were identified that may have contributed to the event.Since this product is not a repairable item, it was disposed of by the manufacturer facility and not returned to the healthcare facility.
 
Event Description
It was reported by the user facility that the attachment was leaking metal shavings.Due to the device being found on a desk with a note, no further information regarding patient involvement, delay, medical intervention, or adverse consequences was provided by the user facility.
 
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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 Key5256840
MDR Text Key32347879
Report Number0001811755-2015-04348
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 11/03/2015
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 Number4100125000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2015
Initial Date FDA Received12/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2015
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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