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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bit, surgical
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFG
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 52 52
2021 68 68
2022 69 69
2023 52 52
2024 79 79
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 205 205
Fracture 92 92
Material Fragmentation 23 23
Entrapment of Device 18 18
Failure to Cut 16 16
Mechanical Jam 8 8
Material Separation 7 7
Device-Device Incompatibility 6 6
Delivered as Unsterile Product 5 5
Residue After Decontamination 5 5
Insufficient Information 4 4
Device Markings/Labelling Problem 3 3
Contamination /Decontamination Problem 3 3
Material Twisted/Bent 3 3
Material Deformation 3 3
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Firing Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Dull, Blunt 2 2
Unstable 1 1
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Crack 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Component Missing 1 1
Misassembled 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
Failure to Cycle 1 1
Difficult to Open or Close 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 248
Foreign Body In Patient 31 31
Insufficient Information 30 30
No Consequences Or Impact To Patient 15 15
No Information 10 10
No Known Impact Or Consequence To Patient 9 9
Device Embedded In Tissue or Plaque 7 7
Injury 3 3
Not Applicable 2 2
Metal Related Pathology 2 2
Failure of Implant 1 1
Perforation 1 1
Cerebrospinal Fluid Leakage 1 1
Spinal Cord Injury 1 1

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