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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, surgical, general & plastic surgery
Product CodeGFF
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 80 80
2020 23 23
2021 76 76
2022 68 68
2023 96 101
2024 34 38

Device Problems MDRs with this Device Problem Events in those MDRs
Break 126 126
Material Fragmentation 80 80
Fracture 53 62
Failure to Cut 27 27
Detachment of Device or Device Component 18 18
Overheating of Device 16 16
Material Twisted/Bent 16 16
Defective Device 11 11
Entrapment of Device 9 9
Excessive Heating 8 8
Melted 5 5
Vibration 5 5
Material Separation 4 4
Device-Device Incompatibility 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Integrity Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Unintended Collision 2 2
Loose or Intermittent Connection 2 2
Flaked 2 2
Loss of or Failure to Bond 1 1
Unintended Ejection 1 1
Thermal Decomposition of Device 1 1
Degraded 1 1
Material Disintegration 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Retraction Problem 1 1
Electro-Static Discharge 1 1
Defective Component 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Smoking 1 1
Unstable 1 1
Material Deformation 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Appropriate Term/Code Not Available 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Scratched Material 1 1
Separation Problem 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 213 222
No Consequences Or Impact To Patient 52 52
Insufficient Information 41 46
Foreign Body In Patient 31 31
Device Embedded In Tissue or Plaque 19 19
No Known Impact Or Consequence To Patient 16 16
Burn, Thermal 5 5
Burn(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Failure of Implant 2 2
No Patient Involvement 2 2
Superficial (First Degree) Burn 1 1
Shock 1 1
Sinus Perforation 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Apr-23-2019
2 Brasseler USA I Lp II Dec-02-2019
3 In2Bones, SAS II Mar-19-2021
4 Wright Medical Technology, Inc. II Nov-25-2019
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