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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hammer, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeFZY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 79 79
2021 69 69
2022 68 68
2023 79 79
2024 83 83
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Break 211 211
Device-Device Incompatibility 95 95
Material Twisted/Bent 49 49
Naturally Worn 46 46
Contamination /Decontamination Problem 38 38
Material Deformation 24 24
Material Integrity Problem 9 9
Mechanical Jam 5 5
Crack 4 4
Appropriate Term/Code Not Available 4 4
Physical Resistance/Sticking 3 3
Scratched Material 3 3
No Apparent Adverse Event 3 3
Illegible Information 3 3
Device Slipped 2 2
Mechanical Problem 2 2
Fracture 2 2
Entrapment of Device 1 1
Device Damaged Prior to Use 1 1
Unintended Movement 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unexpected Therapeutic Results 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 336 336
No Consequences Or Impact To Patient 57 57
Insufficient Information 24 24
No Code Available 11 11
No Patient Involvement 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Skin Infection 1 1
Not Applicable 1 1
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Nerve Damage 1 1

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