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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hammer, surgical
Product CodeFZY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 75 75
2020 79 79
2021 69 69
2022 68 68
2023 79 79
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 203 203
Device-Device Incompatibility 79 79
Material Twisted/Bent 60 60
Naturally Worn 51 51
Material Deformation 19 19
Contamination /Decontamination Problem 14 14
Material Integrity Problem 8 8
Mechanical Jam 4 4
Physical Resistance/Sticking 4 4
Illegible Information 3 3
Scratched Material 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Crack 3 3
Fracture 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Component Missing 1 1
Separation Failure 1 1
Mechanical Problem 1 1
Unexpected Therapeutic Results 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 235 235
No Consequences Or Impact To Patient 109 109
No Patient Involvement 20 20
No Code Available 18 18
Insufficient Information 9 9
Not Applicable 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Known Impact Or Consequence To Patient 2 2
Skin Infection 1 1

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