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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rongeur
Product CodeHTX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 24 24
2020 29 29
2021 26 26
2022 23 23
2023 14 14
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 64 64
Material Fragmentation 13 13
Fracture 12 12
Material Integrity Problem 8 8
Detachment of Device or Device Component 8 8
Material Separation 7 7
Contamination /Decontamination Problem 5 5
Peeled/Delaminated 4 4
Material Erosion 4 4
Device Fell 4 4
Compatibility Problem 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Loose or Intermittent Connection 3 3
Mechanical Problem 2 2
Component Missing 2 2
Material Deformation 2 2
Device Slipped 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1
Structural Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Solder Joint Fracture 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
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 16 16
Foreign Body In Patient 15 15
No Consequences Or Impact To Patient 14 14
Device Embedded In Tissue or Plaque 3 3
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 2 2
Failure of Implant 1 1
No Code Available 1 1
No Information 1 1
No Patient Involvement 1 1
Nerve Damage 1 1
Pain 1 1
Unspecified Tissue Injury 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Ambulation Difficulties 1 1

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