TPLC - Total Product Life Cycle

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Device	reamer
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTO
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14120	14131
Break	1899	1905
Naturally Worn	1872	1877
No Apparent Adverse Event	1056	1056
Corroded	1032	1034
Device-Device Incompatibility	737	739
Adverse Event Without Identified Device or Use Problem	440	440
Entrapment of Device	349	350
Material Twisted/Bent	343	343
Material Deformation	330	330
Contamination /Decontamination Problem	144	146
Fracture	98	98
Illegible Information	93	93
Crack	60	60
Degraded	55	55
Mechanical Jam	42	42
Device Contaminated During Manufacture or Shipping	39	39
Detachment of Device or Device Component	39	40
Material Integrity Problem	38	38
Scratched Material	34	34
Unintended Movement	22	22
Improper or Incorrect Procedure or Method	21	21
Material Discolored	15	15
Inaccurate Information	10	10
Appropriate Device Problem Term/Code Not Available	9	9
Use of Device Problem	9	9
Structural Problem	9	9
Device Slipped	7	7
Dull, Blunt	6	6
Material Fragmentation	4	4
Difficult to Insert	4	4
Difficult to Remove	3	3
Defective Device	3	3
Material Disintegration	3	3
Physical Resistance/Sticking	3	3
Off-Label Use	3	3
Insufficient Device Problem Information	2	2
Product Quality Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Difficult to Open or Close	2	2
Difficult to Open or Remove Packaging Material	2	2
Contamination	1	1
Failure to Clean Adequately	1	1
Device Handling Problem	1	1
Unsealed Device Packaging	1	1
Incorrect Measurement	1	1
Difficult to Advance	1	1
Device Damaged Prior to Use	1	1
Incomplete or Inadequate Connection	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17932	17948
Insufficient Information	1282	1282
Foreign Body In Patient	362	363
Unspecified Tissue Injury	30	30
Limb Fracture	21	21
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	19
Bone Fracture(s)	12	12
Hemorrhage/Blood Loss/Bleeding	6	6
Pain	6	6
Unspecified Infection	5	5
Septic Shock	5	5
Failure of Implant	4	5
Shock	4	4
Device Embedded In Tissue or Plaque	4	4
Embolism/Embolus	3	3
Cardiac Arrest	3	3
Post Operative Wound Infection	3	3
Loss of Range of Motion	3	3
Discomfort	2	2
No Patient Involvement	2	2
Fall	2	2
Nonunion/Delayed-union Bone Fracture	2	3
Swelling/ Edema	2	2
Hematoma	1	1
Multiple Fractures	1	1
Unspecified Nervous System Problem	1	1
Burn(s)	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Hyperextension	1	1
Perforation of Vessels	1	1
Skin Tears	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1