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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device driver, prosthesis
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWR
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 738 738
2021 898 900
2022 979 986
2023 1280 1285
2024 1211 1216
2025 1089 1089

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2938 2945
Material Twisted/Bent 1805 1806
Device-Device Incompatibility 798 801
Naturally Worn 354 357
Material Deformation 320 320
Crack 201 201
Entrapment of Device 117 118
Fracture 91 94
Mechanical Problem 89 89
Mechanical Jam 83 83
Material Integrity Problem 80 81
No Apparent Adverse Event 52 52
Contamination /Decontamination Problem 44 44
Unintended Movement 32 32
Failure to Cut 26 26
Detachment of Device or Device Component 24 24
Adverse Event Without Identified Device or Use Problem 21 21
Appropriate Term/Code Not Available 16 16
Corroded 14 14
Structural Problem 13 13
Device Slipped 13 13
Scratched Material 12 13
Illegible Information 12 12
Component Missing 11 11
Calibration Problem 7 7
Physical Resistance/Sticking 7 7
Material Fragmentation 5 5
Use of Device Problem 5 6
Material Split, Cut or Torn 4 4
Defective Device 3 3
Loose or Intermittent Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 2 2
Flaked 2 2
Device Fell 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1
Material Discolored 1 1
Moisture or Humidity Problem 1 2
Material Separation 1 1
Off-Label Use 1 1
Device Reprocessing Problem 1 2
Nonstandard Device 1 1
Connection Problem 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5021 5037
No Consequences Or Impact To Patient 554 554
Insufficient Information 535 537
Foreign Body In Patient 91 93
No Code Available 86 86
No Patient Involvement 31 31
Not Applicable 6 6
No Information 6 6
Limb Fracture 5 5
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Pain 2 2
Unspecified Infection 1 1
Neuropathy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Bone Fracture(s) 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Nerve Damage 1 1
Device Embedded In Tissue or Plaque 1 1

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