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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 898 898
2022 980 980
2023 1281 1281
2024 1213 1213
2025 181 181

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2494 2494
Material Twisted/Bent 1527 1527
Device-Device Incompatibility 693 693
Naturally Worn 355 355
Material Deformation 226 226
Crack 194 194
Entrapment of Device 96 96
Fracture 73 73
Mechanical Problem 73 73
Material Integrity Problem 73 73
Mechanical Jam 72 72
Contamination /Decontamination Problem 40 40
Failure to Cut 26 26
Unintended Movement 26 26
No Apparent Adverse Event 24 24
Detachment of Device or Device Component 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Appropriate Term/Code Not Available 16 16
Scratched Material 12 12
Device Slipped 12 12
Component Missing 11 11
Structural Problem 11 11
Corroded 10 10
Physical Resistance/Sticking 7 7
Calibration Problem 7 7
Use of Device Problem 5 5
Illegible Information 4 4
Material Split, Cut or Torn 4 4
Loose or Intermittent Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Device 2 2
Defective Component 2 2
Material Fragmentation 2 2
Material Discolored 2 2
Flaked 2 2
Device Fell 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1
Moisture or Humidity Problem 1 1
Off-Label Use 1 1
Material Separation 1 1
Device Reprocessing Problem 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 4219 4219
No Consequences Or Impact To Patient 554 554
Insufficient Information 459 459
No Code Available 86 86
Foreign Body In Patient 62 62
No Patient Involvement 31 31
Not Applicable 6 6
No Information 6 6
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Limb Fracture 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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