TPLC - Total Product Life Cycle

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Device	broach
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTQ
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1431	1431
Break	550	550
Unintended Movement	329	329
Failure to Cut	238	238
Material Deformation	210	210
Scratched Material	198	198
Naturally Worn	167	167
Difficult to Advance	116	116
Material Twisted/Bent	100	100
Adverse Event Without Identified Device or Use Problem	87	87
Structural Problem	78	78
Fracture	62	62
Loose or Intermittent Connection	61	61
Dull, Blunt	50	50
Device Damaged Prior to Use	46	46
No Apparent Adverse Event	42	42
Material Integrity Problem	40	40
Physical Resistance/Sticking	36	36
Contamination /Decontamination Problem	36	36
Mechanical Jam	34	34
Device Slipped	29	29
Chemical Problem	29	29
Inadequacy of Device Shape and/or Size	27	27
Illegible Information	26	26
Connection Problem	24	24
Difficult to Open or Close	19	19
Entrapment of Device	17	17
Crack	16	16
Missing Information	16	16
Appropriate Term/Code Not Available	15	15
Fitting Problem	13	13
Detachment of Device or Device Component	12	12
Component Missing	11	11
Device Dislodged or Dislocated	10	10
Device Contaminated During Manufacture or Shipping	9	9
Difficult to Remove	8	8
Positioning Problem	6	6
Device Markings/Labelling Problem	6	6
Defective Device	4	4
Tear, Rip or Hole in Device Packaging	4	4
Device Contamination with Chemical or Other Material	4	4
Off-Label Use	4	4
Corroded	4	4
Difficult to Insert	3	3
Use of Device Problem	3	3
Device Damaged by Another Device	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Insufficient Information	2	2
Incomplete or Inadequate Connection	2	2
Failure to Advance	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1853	1853
No Consequences Or Impact To Patient	731	731
Insufficient Information	324	324
No Code Available	143	143
Not Applicable	57	57
Bone Fracture(s)	35	35
No Known Impact Or Consequence To Patient	27	27
Limb Fracture	25	25
Unspecified Tissue Injury	16	16
Pain	12	12
Joint Dislocation	10	10
Unspecified Infection	9	9
No Information	9	9
Joint Laxity	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Foreign Body In Patient	4	4
No Patient Involvement	4	4
Loss of Range of Motion	2	2
Damage to Ligament(s)	1	1
Fatigue	1	1
Inadequate Osseointegration	1	1
Foreign Body Reaction	1	1
Thrombosis/Thrombus	1	1
Nerve Damage	1	1
Discomfort	1	1
Fall	1	1
Scar Tissue	1	1
Physical Asymmetry	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1