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TPLC
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show TPLC since
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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
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
34
34
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
116
116
Material Integrity Problem
32
32
Failure to Cut
13
13
Fracture
13
13
Dull, Blunt
10
10
Material Deformation
7
7
Mechanical Problem
5
5
Crack
4
4
Material Fragmentation
3
3
Contamination /Decontamination Problem
3
3
Naturally Worn
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Detachment of Device or Device Component
2
2
Device Slipped
2
2
Activation, Positioning or Separation Problem
2
2
Device-Device Incompatibility
1
1
Material Frayed
1
1
Mechanical Jam
1
1
Defective Device
1
1
Device Fell
1
1
Flaked
1
1
Material Twisted/Bent
1
1
No Apparent Adverse Event
1
1
Physical Resistance/Sticking
1
1
Difficult to Open or Close
1
1
Compatibility Problem
1
1
Packaging Problem
1
1
Corroded
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
136
136
No Consequences Or Impact To Patient
28
28
No Patient Involvement
15
15
Insufficient Information
10
10
No Known Impact Or Consequence To Patient
9
9
Foreign Body In Patient
6
6
No Information
3
3
No Code Available
3
3
Laceration(s)
1
1
Tissue Damage
1
1
Device Embedded In Tissue or Plaque
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
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