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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
The user facility reported that the device had metal fragments coming out during a procedure.Patient wound was washed out.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported that the device had metal fragments coming out during a procedure.Patient wound was washed out.
 
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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
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12933589
MDR Text Key281749355
Report Number3015967359-2021-02673
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068354
UDI-Public04546540068354
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? No
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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