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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bit, surgical
Product CodeGFG
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 20 20
2020 52 52
2021 68 68
2022 69 69
2023 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Break 147 147
Fracture 50 50
Entrapment of Device 19 19
Material Fragmentation 18 18
Failure to Cut 13 13
Material Separation 10 10
Device-Device Incompatibility 8 8
Mechanical Jam 6 6
Residue After Decontamination 5 5
Dull, Blunt 4 4
Contamination /Decontamination Problem 3 3
Device Markings/Labelling Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Firing Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Flaked 1 1
Mechanical Problem 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Difficult to Remove 1 1
Detachment Of Device Component 1 1
Crack 1 1
Material Discolored 1 1
Activation Problem 1 1
Material Deformation 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Detachment of Device or Device Component 1 1
Failure to Align 1 1
Failure to Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
Foreign Body In Patient 32 32
No Consequences Or Impact To Patient 31 31
Insufficient Information 21 21
No Known Impact Or Consequence To Patient 13 13
Device Embedded In Tissue or Plaque 11 11
No Information 11 11
Injury 4 4
Not Applicable 3 3
No Code Available 3 3
No Patient Involvement 3 3
Metal Related Pathology 1 1
Spinal Cord Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Failure of Implant 1 1
Tissue Damage 1 1

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