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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
2017 32 32
2018 47 47
2019 109 109
2020 87 87
2021 230 230

Device Problems MDRs with this Device Problem Events in those MDRs
Break 151 151
Device-Device Incompatibility 102 102
Material Deformation 58 58
Naturally Worn 51 51
Material Twisted/Bent 42 42
Mechanical Jam 23 23
Scratched Material 23 23
Physical Resistance/Sticking 22 22
Corroded 16 16
Crack 12 12
Mechanical Problem 11 11
Appropriate Term/Code Not Available 9 9
Material Integrity Problem 8 8
Contamination /Decontamination Problem 8 8
Activation, Positioning or SeparationProblem 8 8
Difficult to Remove 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Cut 5 5
Material Frayed 5 5
Detachment of Device or Device Component 5 5
Connection Problem 4 4
Loose or Intermittent Connection 4 4
Illegible Information 4 4
Cut In Material 3 3
Device Issue 2 2
Device Operates Differently Than Expected 2 2
Device Damaged by Another Device 2 2
Material Discolored 2 2
Entrapment of Device 2 2
Sharp Edges 2 2
Bent 1 1
Display Difficult to Read 1 1
Degraded 1 1
Disassembly 1 1
Incorrect Measurement 1 1
Difficult to Insert 1 1
Material Separation 1 1
Use of Device Problem 1 1
Component Missing 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Dull, Blunt 1 1
Off-Label Use 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 231 231
No Consequences Or Impact To Patient 168 168
No Known Impact Or Consequence To Patient 30 30
No Patient Involvement 27 27
No Code Available 16 16
Insufficient Information 15 15
Not Applicable 14 14
No Information 10 10
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Pain 1 1
Injury 1 1
Disability 1 1
Joint Dislocation 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1

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