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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 466 466
2021 550 550
2022 506 506
2023 586 586
2024 477 477
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1205 1205
Break 459 459
Unintended Movement 273 273
Failure to Cut 238 238
Material Deformation 183 183
Naturally Worn 154 154
Scratched Material 133 133
Difficult to Advance 116 116
Adverse Event Without Identified Device or Use Problem 79 79
Structural Problem 75 75
Material Twisted/Bent 70 70
Fracture 45 45
Device Damaged Prior to Use 44 44
No Apparent Adverse Event 42 42
Material Integrity Problem 38 38
Dull, Blunt 33 33
Contamination /Decontamination Problem 31 31
Chemical Problem 29 29
Mechanical Jam 27 27
Loose or Intermittent Connection 25 25
Illegible Information 25 25
Physical Resistance/Sticking 24 24
Inadequacy of Device Shape and/or Size 24 24
Device Slipped 19 19
Missing Information 16 16
Difficult to Open or Close 16 16
Entrapment of Device 14 14
Detachment of Device or Device Component 11 11
Crack 10 10
Device Dislodged or Dislocated 10 10
Device Contaminated During Manufacture or Shipping 9 9
Tear, Rip or Hole in Device Packaging 7 7
Device Markings/Labelling Problem 6 6
Off-Label Use 4 4
Corroded 4 4
Defective Device 3 3
Device Damaged by Another Device 3 3
Use of Device Problem 3 3
Difficult to Remove 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Discolored 1 1
Component Missing 1 1
Positioning Problem 1 1
Noise, Audible 1 1
Backflow 1 1
Mechanical Problem 1 1
Material Frayed 1 1
Difficult to Open or Remove Packaging Material 1 1
Appropriate Term/Code Not Available 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1830 1830
No Consequences Or Impact To Patient 338 338
Insufficient Information 318 318
No Code Available 137 137
Bone Fracture(s) 26 26
Limb Fracture 25 25
Not Applicable 19 19
No Known Impact Or Consequence To Patient 18 18
Unspecified Tissue Injury 16 16
Pain 11 11
Joint Dislocation 10 10
Unspecified Infection 8 8
Joint Laxity 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Patient Involvement 3 3
Foreign Body In Patient 3 3
Loss of Range of Motion 2 2
No Information 2 2
Deformity/ Disfigurement 1 1
Thrombosis/Thrombus 1 1
Nerve Damage 1 1
Foreign Body Reaction 1 1
Physical Asymmetry 1 1
Fall 1 1
Distress 1 1
Damage to Ligament(s) 1 1
Fatigue 1 1
Low Blood Pressure/ Hypotension 1 1
Scar Tissue 1 1
Discomfort 1 1

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