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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 2 2
2020 8 8
2021 8 8
2022 1 1
2023 4 4
2024 4 4
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Material Fragmentation 3 3
Use of Device Problem 2 2
Material Deformation 2 2
Insufficient Information 1 1
Sharp Edges 1 1
Detachment of Device or Device Component 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 4 4
Foreign Body In Patient 2 2
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Implant Resource Inc II Oct-16-2021
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