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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE Back to Search Results
Model Number 4100062000
Device Problems Material Disintegration (1177); Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
Event Date 03/17/2020
Event Type  malfunction  
Event Description
The user facility reported the device expelled metal shavings during inspection.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported the device expelled metal shavings during inspection.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
WIRE COLLET
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9898285
MDR Text Key186728702
Report Number0001811755-2020-00812
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068354
UDI-Public04546540068354
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/27/2020
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 No Information
Device Model Number4100062000
Device Catalogue Number4100062000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received03/30/2020
Supplement Dates Manufacturer Received05/27/2020
Supplement Dates FDA Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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