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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rongeur
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 26 26
2022 23 23
2023 14 14
2024 24 24
2025 16 16
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Fracture 10 10
Material Integrity Problem 9 9
Material Fragmentation 8 8
Detachment of Device or Device Component 6 6
Contamination /Decontamination Problem 5 5
Material Separation 5 5
Compatibility Problem 3 3
Mechanical Problem 3 3
Material Twisted/Bent 3 3
Loose or Intermittent Connection 2 2
Device Slipped 1 1
Separation Failure 1 1
Unintended Movement 1 1
Failure to Align 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
Foreign Body In Patient 14 14
Insufficient Information 13 13
Device Embedded In Tissue or Plaque 2 2
Bone Fracture(s) 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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