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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 52 52
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Break 174 174
Fracture 55 55
Entrapment of Device 22 22
Material Fragmentation 22 22
Failure to Cut 17 17
Material Separation 10 10
Mechanical Jam 8 8
Device-Device Incompatibility 8 8
Residue After Decontamination 5 5
Dull, Blunt 4 4
Contamination /Decontamination Problem 3 3
Device Markings/Labelling Problem 3 3
Insufficient Information 3 3
Delivered as Unsterile Product 3 3
Improper or Incorrect Procedure or Method 2 2
Firing Problem 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Flaked 1 1
Failure to Cycle 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Fire 1 1
No Apparent Adverse Event 1 1
Detachment of Device or Device Component 1 1
Misassembled 1 1
Material Discolored 1 1
Failure to Align 1 1
Component Missing 1 1
Use of Device Problem 1 1
Crack 1 1
Material Split, Cut or Torn 1 1
Unstable 1 1
Detachment Of Device Component 1 1
Difficult to Open or Close 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Remove 1 1
Mechanical Problem 1 1
Activation Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 192 192
Foreign Body In Patient 37 37
No Consequences Or Impact To Patient 31 31
Insufficient Information 26 26
No Known Impact Or Consequence To Patient 13 13
No Information 11 11
Device Embedded In Tissue or Plaque 11 11
Injury 4 4
No Code Available 3 3
Not Applicable 3 3
No Patient Involvement 3 3
Failure of Implant 1 1
Metal Related Pathology 1 1
Perforation 1 1
Tissue Damage 1 1
Cerebrospinal Fluid Leakage 1 1
Spinal Cord Injury 1 1

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