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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
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFF
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2021 76 76
2022 68 68
2023 96 101
2024 124 134
2025 72 74
2026 53 55

Device Problems MDRs with this Device Problem Events in those MDRs
Break 165 165
Material Fragmentation 107 107
Fracture 52 71
Failure to Cut 26 26
Material Twisted/Bent 20 20
Detachment of Device or Device Component 17 17
Defective Device 14 14
Device Contaminated During Manufacture or Shipping 12 12
Defective Component 9 9
Entrapment of Device 7 7
Melted 7 7
Physical Resistance/Sticking 7 7
Use of Device Problem 7 7
Excessive Heating 6 6
Device-Device Incompatibility 5 5
Overheating of Device 5 5
Material Separation 4 4
Material Integrity Problem 4 4
Mechanical Jam 3 3
Material Split, Cut or Torn 3 3
Device Emits Odor 3 3
Temperature Problem 2 2
Loose or Intermittent Connection 2 2
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Retraction Problem 2 2
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Unintended Movement 2 2
Output Problem 2 2
Device Difficult to Setup or Prepare 1 1
Unintended Ejection 1 1
Thermal Decomposition of Device 1 1
Degraded 1 1
Device Damaged by Another Device 1 1
Mechanics Altered 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Smoking 1 1
Product Quality Problem 1 1
Failure to Sense 1 1
Failure to Fire 1 1
Separation Failure 1 1
Activation Failure 1 1
Material Disintegration 1 1
Complete Blockage 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 381 400
Insufficient Information 77 88
Foreign Body In Patient 39 39
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Burn(s) 3 3
Superficial (First Degree) Burn 1 1
Failure of Implant 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Sinus Perforation 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 In2Bones, SAS II Mar-19-2021
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