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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
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
Appropriate Term/Code Not Available 2 2
Loose or Intermittent Connection 2 2
Device Slipped 1 1
Separation Failure 1 1
Unintended Movement 1 1
Positioning Problem 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
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
Foreign Body In Patient 15 15
Insufficient Information 13 13
Bone Fracture(s) 2 2
Device Embedded In Tissue or Plaque 2 2
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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