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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device broach
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 460 460
2020 466 466
2021 550 550
2022 506 506
2023 586 586
2024 169 169

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1202 1202
Break 475 475
Unintended Movement 270 270
Failure to Cut 238 238
Scratched Material 180 180
Material Deformation 180 180
Naturally Worn 148 148
Difficult to Advance 115 115
Material Twisted/Bent 100 100
Adverse Event Without Identified Device or Use Problem 80 80
Structural Problem 66 66
Loose or Intermittent Connection 61 61
Fracture 60 60
Dull, Blunt 50 50
Device Damaged Prior to Use 40 40
Physical Resistance/Sticking 36 36
Mechanical Jam 34 34
Material Integrity Problem 33 33
Contamination /Decontamination Problem 33 33
Device Slipped 29 29
Inadequacy of Device Shape and/or Size 27 27
Chemical Problem 25 25
No Apparent Adverse Event 25 25
Connection Problem 24 24
Illegible Information 23 23
Difficult to Open or Close 17 17
Entrapment of Device 16 16
Appropriate Term/Code Not Available 15 15
Fitting Problem 13 13
Component Missing 11 11
Detachment of Device or Device Component 11 11
Crack 10 10
Device Dislodged or Dislocated 9 9
Difficult to Remove 8 8
Tear, Rip or Hole in Device Packaging 7 7
Device Markings/Labelling Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
Positioning Problem 6 6
Device Contamination with Chemical or Other Material 4 4
Defective Device 4 4
Off-Label Use 4 4
Corroded 4 4
Use of Device Problem 3 3
Difficult to Insert 3 3
Device Damaged by Another Device 3 3
Failure to Advance 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Insufficient Information 2 2
Incomplete or Inadequate Connection 2 2
Failure to Clean Adequately 1 1
Noise, Audible 1 1
Migration 1 1
Output Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Problem 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Material Discolored 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1610 1610
No Consequences Or Impact To Patient 731 731
Insufficient Information 203 203
No Code Available 143 143
Not Applicable 57 57
Bone Fracture(s) 35 35
No Known Impact Or Consequence To Patient 27 27
Limb Fracture 21 21
Unspecified Tissue Injury 12 12
Pain 10 10
Joint Dislocation 9 9
No Information 9 9
Unspecified Infection 8 8
Joint Laxity 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Patient Involvement 4 4
Foreign Body In Patient 3 3
Loss of Range of Motion 2 2
Scar Tissue 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Low Blood Pressure/ Hypotension 1 1
Fall 1 1
Fatigue 1 1
Foreign Body Reaction 1 1
Inadequate Osseointegration 1 1
Distress 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Physical Asymmetry 1 1
Thrombosis/Thrombus 1 1

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