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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
2019 20 20
2020 52 52
2021 68 68
2022 69 69
2023 52 52
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 143 143
Fracture 48 48
Material Fragmentation 19 19
Entrapment of Device 16 16
Failure to Cut 13 13
Material Separation 9 9
Device-Device Incompatibility 8 8
Mechanical Jam 7 7
Residue After Decontamination 5 5
Insufficient Information 3 3
Device Markings/Labelling Problem 3 3
Contamination /Decontamination Problem 3 3
Delivered as Unsterile Product 3 3
Firing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Dull, Blunt 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Tear, Rip or Hole in Device Packaging 1 1
Flaked 1 1
Crack 1 1
Material Discolored 1 1
Mechanical Problem 1 1
Misassembled 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Material Split, Cut or Torn 1 1
Detachment of Device or Device Component 1 1
Failure to Fire 1 1
Device Misassembled During Manufacturing /Shipping 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 177 177
Foreign Body In Patient 28 28
No Consequences Or Impact To Patient 23 23
Insufficient Information 22 22
No Information 11 11
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 7 7
Injury 4 4
Not Applicable 3 3
No Patient Involvement 2 2
Metal Related Pathology 1 1
Spinal Cord Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Failure of Implant 1 1

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