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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADJUSTABLE PIN COLLET (2.0-3.2MM); ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO ADJUSTABLE PIN COLLET (2.0-3.2MM); ARTHROSCOPE Back to Search Results
Model Number 4100126000
Device Problem Material Disintegration (1177)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Event Description
The user facility reported that the device had black powder coming out during testing.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event Description
The user facility reported that the device had black powder coming out during testing.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Additional information: d10.Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
ADJUSTABLE PIN COLLET (2.0-3.2MM)
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11435791
MDR Text Key238386651
Report Number3015967359-2021-00096
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540377982
UDI-Public04546540377982
Combination Product (y/n)N
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/16/2021
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 Model Number4100126000
Device Catalogue Number4100126000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Initial Date Manufacturer Received 02/12/2021
Initial Date FDA Received03/08/2021
Supplement Dates Manufacturer Received04/14/2021
Supplement Dates FDA Received04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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