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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
2014 15 15
2015 38 38
2016 28 28
2017 26 26
2018 25 25
2019 24 24
2020 29 29
2021 26 26
2022 23 23
2023 14 14
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 138 138
Fracture 25 25
Material Fragmentation 21 21
Detachment Of Device Component 13 13
Component Missing 9 9
Detachment of Device or Device Component 9 9
Contamination /Decontamination Problem 6 6
Material Integrity Problem 6 6
Material Separation 6 6
Component Falling 5 5
Material Deformation 5 5
Appropriate Term/Code Not Available 5 5
Device Fell 4 4
Material Twisted/Bent 4 4
Material Erosion 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Bent 4 4
Peeled/Delaminated 4 4
Device Operates Differently Than Expected 3 3
Device Dislodged or Dislocated 3 3
Compatibility Problem 3 3
Insufficient Information 3 3
Missing Value Reason 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Or Device Fragments Location Unknown 2 2
Difficult to Remove 2 2
Entrapment of Device 2 2
Device Slipped 1 1
Device Inoperable 1 1
Unstable 1 1
Delivered as Unsterile Product 1 1
Corroded 1 1
Material Discolored 1 1
Difficult to Open or Close 1 1
Solder Joint Fracture 1 1
Structural Problem 1 1
Failure to Cut 1 1
Material Torqued 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 89 89
No Clinical Signs, Symptoms or Conditions 59 59
No Consequences Or Impact To Patient 27 27
Foreign Body In Patient 24 24
No Patient Involvement 16 16
Insufficient Information 16 16
Device Embedded In Tissue or Plaque 12 12
No Information 7 7
No Code Available 7 7
Hemorrhage/Bleeding 3 3
Pain 2 2
Missing Value Reason 2 2
Patient Problem/Medical Problem 2 2
Unspecified Tissue Injury 1 1
Atrial Fibrillation 1 1
Failure of Implant 1 1
Nerve Damage 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jul-03-2017
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