Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
cutter, wire
Product Code
HXZ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
29
29
2015
24
24
2016
33
33
2017
25
25
2018
26
26
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
198
198
Material Integrity Problem
32
32
Fracture
23
23
Material Fragmentation
15
15
Dull, Blunt
14
14
Failure to Cut
14
14
Device Operates Differently Than Expected
8
8
Material Deformation
8
8
Component Missing
6
6
Mechanical Problem
6
6
Device Inoperable
4
4
Contamination /Decontamination Problem
4
4
Crack
4
4
Detachment of Device or Device Component
3
3
Mechanical Jam
3
3
Device Slipped
3
3
Naturally Worn
3
3
Flaked
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Activation, Positioning or Separation Problem
2
2
No Apparent Adverse Event
1
1
Delivered as Unsterile Product
1
1
Packaging Problem
1
1
Bent
1
1
Material Twisted/Bent
1
1
Delamination
1
1
Expiration Date Error
1
1
Defective Device
1
1
Device Expiration Issue
1
1
Device Fell
1
1
Insufficient Information
1
1
Device Operational Issue
1
1
Physical Resistance/Sticking
1
1
Tip breakage
1
1
Device-Device Incompatibility
1
1
Leak/Splash
1
1
Compatibility Problem
1
1
Material Frayed
1
1
Pressure Problem
1
1
Component Falling
1
1
Corroded
1
1
Difficult to Open or Close
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
128
128
No Known Impact Or Consequence To Patient
73
73
No Consequences Or Impact To Patient
54
54
No Patient Involvement
52
52
No Code Available
12
12
Insufficient Information
9
9
No Information
8
8
Foreign Body In Patient
8
8
Device Embedded In Tissue or Plaque
2
2
Brain Injury
1
1
Blood Loss
1
1
Alteration In Body Temperature
1
1
Weakness
1
1
Laceration(s)
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Spinal Cord Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
-
-