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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
cutter, wire
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HXZ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
34
34
2025
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
112
112
Material Integrity Problem
31
31
Fracture
13
13
Failure to Cut
7
7
Mechanical Problem
5
5
Crack
5
5
Material Deformation
5
5
Contamination /Decontamination Problem
3
3
Material Fragmentation
3
3
Device Slipped
2
2
Activation, Positioning or Separation Problem
2
2
Material Twisted/Bent
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Detachment of Device or Device Component
2
2
Material Frayed
1
1
Device-Device Incompatibility
1
1
Compatibility Problem
1
1
Device Fell
1
1
No Apparent Adverse Event
1
1
Naturally Worn
1
1
Corroded
1
1
Flaked
1
1
Mechanical Jam
1
1
Dull, Blunt
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
146
146
No Consequences Or Impact To Patient
16
16
Insufficient Information
14
14
Foreign Body In Patient
6
6
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
3
3
No Code Available
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
-
-