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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
2021 88 88
2022 64 64
2023 82 82
2024 83 83
2025 181 181
2026 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Break 279 279
Device-Device Incompatibility 93 93
Naturally Worn 39 39
Material Deformation 38 38
Crack 35 35
Material Twisted/Bent 32 32
Failure to Cut 15 15
Entrapment of Device 15 15
Mechanical Jam 14 14
Detachment of Device or Device Component 11 11
Fracture 10 10
Residue After Decontamination 10 10
Structural Problem 10 10
Scratched Material 5 5
No Apparent Adverse Event 5 5
Contamination /Decontamination Problem 4 4
Difficult to Open or Close 4 4
Material Too Rigid or Stiff 4 4
Unintended Movement 4 4
Difficult to Insert 3 3
Mechanical Problem 3 3
Corroded 3 3
Material Discolored 3 3
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Failure to Align 2 2
Device Slipped 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Positioning Failure 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Illegible Information 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 485 485
Insufficient Information 61 61
Foreign Body In Patient 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body Reaction 1 1
No Consequences Or Impact To Patient 1 1

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