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	1314	1345
Break	605	621
Unintended Movement	311	311
Failure to Cut	238	238
Material Deformation	194	196
Naturally Worn	154	154
Scratched Material	137	137
Difficult to Advance	118	118
Structural Problem	90	90
Adverse Event Without Identified Device or Use Problem	75	75
Material Twisted/Bent	70	70
Fracture	51	52
Device Damaged Prior to Use	44	44
No Apparent Adverse Event	43	43
Material Integrity Problem	41	41
Dull, Blunt	33	33
Contamination /Decontamination Problem	32	32
Illegible Information	29	29
Chemical Problem	28	28
Mechanical Jam	27	27
Loose or Intermittent Connection	25	25
Inadequacy of Device Shape and/or Size	25	25
Physical Resistance/Sticking	24	24
Device Slipped	19	19
Difficult to Open or Close	17	17
Detachment of Device or Device Component	16	16
Missing Information	16	16
Entrapment of Device	15	15
Crack	11	11
Device Contaminated During Manufacture or Shipping	8	8
Device Markings/Labelling Problem	6	6
Device Dislodged or Dislocated	6	6
Tear, Rip or Hole in Device Packaging	4	4
Off-Label Use	4	4
Corroded	4	4
Use of Device Problem	3	3
Difficult to Remove	3	3
Device Damaged by Another Device	3	3
Defective Device	3	3
Positioning Failure	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Backflow	1	1
Material Discolored	1	1
Component Missing	1	1
Positioning Problem	1	1
Separation Failure	1	1
Output Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2075	2110
No Consequences Or Impact To Patient	338	338
Insufficient Information	337	338
No Code Available	137	137
Bone Fracture(s)	28	28
Limb Fracture	27	27
Not Applicable	19	19
No Known Impact Or Consequence To Patient	18	18
Unspecified Tissue Injury	15	15
Pain	7	7
Joint Dislocation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Foreign Body In Patient	4	4
Joint Laxity	4	4
Unspecified Infection	3	3
No Patient Involvement	3	3
Arthralgia	2	2
No Information	2	2
Deformity/ Disfigurement	2	2
Damage to Ligament(s)	1	1
Thrombosis/Thrombus	1	1
Nerve Damage	1	1
Discomfort	1	1
Scar Tissue	1	1
Distress	1	1