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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, cutting, orthopedic
Regulation Description Manual surgical instrument for general use.
Product CodeHTZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 34 34
2017 32 32
2018 47 47
2019 109 109
2020 87 87
2021 188 188

Device Problems MDRs with this Device Problem Events in those MDRs
Break 164 164
Device-Device Incompatibility 95 95
Material Deformation 49 49
Material Twisted/Bent 42 42
Naturally Worn 37 37
Scratched Material 23 23
Physical Resistance/Sticking 22 22
Mechanical Jam 20 20
Corroded 16 16
Crack 12 12
Appropriate Term/Code Not Available 12 12
Mechanical Problem 10 10
Difficult to Remove 10 10
Activation, Positioning or SeparationProblem 8 8
Contamination /Decontamination Problem 8 8
Material Integrity Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Detachment of Device or Device Component 7 7
Loose or Intermittent Connection 5 5
Material Frayed 5 5
Failure to Cut 5 5
Illegible Information 4 4
Connection Problem 4 4
Material Fragmentation 3 3
Device Operates Differently Than Expected 3 3
Cut In Material 3 3
Component Missing 2 2
Device Issue 2 2
Material Separation 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Entrapment of Device 2 2
Material Discolored 2 2
Sharp Edges 2 2
Display Difficult to Read 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Degraded 1 1
Disassembly 1 1
Bent 1 1
Difficult to Insert 1 1
Off-Label Use 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Sticking 1 1
Use of Device Problem 1 1
Dull, Blunt 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 192 192
No Consequences Or Impact To Patient 168 168
No Known Impact Or Consequence To Patient 50 50
No Patient Involvement 36 36
No Code Available 16 16
Not Applicable 14 14
No Information 13 13
Insufficient Information 11 11
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Pain 2 2
Swelling 1 1
Dysphagia/ Odynophagia 1 1
Failure of Implant 1 1
Injury 1 1
Disability 1 1
Joint Dislocation 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Feb-13-2020
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