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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
Product CodeHTZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 109 109
2020 87 87
2021 229 229
2022 196 196
2023 188 188
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 288 288
Device-Device Incompatibility 209 209
Naturally Worn 122 122
Material Deformation 121 121
Material Twisted/Bent 38 38
Scratched Material 35 35
Mechanical Jam 32 32
Corroded 29 29
Crack 23 23
Physical Resistance/Sticking 22 22
Material Integrity Problem 19 19
Contamination /Decontamination Problem 13 13
Detachment of Device or Device Component 12 12
Mechanical Problem 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Illegible Information 10 10
Activation, Positioning or Separation Problem 8 8
Failure to Cut 8 8
Material Frayed 5 5
Difficult to Remove 5 5
Structural Problem 4 4
Appropriate Term/Code Not Available 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Failure to Disconnect 2 2
Sharp Edges 2 2
Unintended Movement 2 2
Device Damaged by Another Device 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Connection Problem 2 2
Self-Activation or Keying 1 1
Difficult to Open or Close 1 1
Incorrect Measurement 1 1
Degraded 1 1
Device Dislodged or Dislocated 1 1
Display Difficult to Read 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Positioning Problem 1 1
Difficult to Advance 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 638 638
No Consequences Or Impact To Patient 134 134
Insufficient Information 49 49
No Patient Involvement 20 20
No Known Impact Or Consequence To Patient 10 10
Not Applicable 10 10
No Code Available 10 10
Unspecified Tissue Injury 3 3
Foreign Body In Patient 3 3
Post Operative Wound Infection 2 2
Hemorrhage/Bleeding 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Pain 1 1
Paralysis 1 1
Cerebrospinal Fluid Leakage 1 1
Joint Dislocation 1 1
Spinal Cord Injury 1 1

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