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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 Problem Material Disintegration (1177)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2020
Event Type  malfunction  
Event Description
The user facility reported the device emitted metal shavings during use.  there was no known patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Device not returned.
 
Event Description
The user facility reported the device emitted metal shavings during use.  there was no known 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
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key9777436
MDR Text Key181766748
Report Number0001811755-2020-00604
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068354
UDI-Public04546540068354
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 12/23/2020
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 Health Professional
Device Model Number4100062000
Device Catalogue Number4100062000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/21/2020
Initial Date FDA Received03/02/2020
Supplement Dates Manufacturer Received02/21/2020
Supplement Dates FDA Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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