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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, compression
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWN
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 51 51
2021 88 88
2022 64 64
2023 83 83
2024 83 83
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 188 188
Device-Device Incompatibility 77 77
Naturally Worn 41 41
Crack 39 39
Material Deformation 32 32
Material Twisted/Bent 20 20
Entrapment of Device 13 13
Mechanical Jam 11 11
Structural Problem 10 10
Detachment of Device or Device Component 9 9
Contamination /Decontamination Problem 8 8
Scratched Material 8 8
Fracture 8 8
Material Too Rigid or Stiff 4 4
Difficult to Open or Close 4 4
Device Slipped 3 3
Mechanical Problem 3 3
Unintended Movement 3 3
Difficult to Insert 3 3
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Material Fragmentation 2 2
Component Missing 2 2
Failure to Align 2 2
No Apparent Adverse Event 2 2
Corroded 2 2
Material Frayed 1 1
Off-Label Use 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 306 306
Insufficient Information 42 42
No Consequences Or Impact To Patient 41 41
Foreign Body In Patient 16 16
No Code Available 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1

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