TPLC - Total Product Life Cycle

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Device	instrument, cutting, orthopedic
Regulation Description	Manual surgical instrument for general use.
Product Code	HTZ
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	357	358
Device-Device Incompatibility	240	242
Material Deformation	191	193
Naturally Worn	155	155
Failure to Cut	80	81
Scratched Material	66	66
Material Integrity Problem	30	30
Crack	25	25
Mechanical Jam	21	21
No Apparent Adverse Event	15	15
Corroded	15	15
Material Twisted/Bent	14	14
Detachment of Device or Device Component	14	14
Contamination /Decontamination Problem	10	11
Illegible Information	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Incorrect Measurement	9	9
Unintended Movement	5	5
Entrapment of Device	4	4
Material Discolored	4	4
Structural Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Mechanical Problem	2	2
Patient-Device Incompatibility	2	2
Use of Device Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Device Slipped	1	1
Off-Label Use	1	1
Difficult to Advance	1	1
Positioning Problem	1	1
Material Fragmentation	1	1
Fracture	1	1
Self-Activation or Keying	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	987	991
Insufficient Information	111	111
Unspecified Tissue Injury	3	3
Post Operative Wound Infection	2	2
Foreign Body In Patient	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Paralysis	1	1
Nerve Damage	1	1
Pain	1	1
Cerebrospinal Fluid Leakage	1	1
Spinal Cord Injury	1	1