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	1148	1179
Break	517	533
Unintended Movement	285	285
Failure to Cut	203	203
Material Deformation	161	163
Naturally Worn	144	144
Difficult to Advance	118	118
Scratched Material	100	100
Structural Problem	77	77
Adverse Event Without Identified Device or Use Problem	59	59
Device Damaged Prior to Use	44	44
No Apparent Adverse Event	43	43
Material Integrity Problem	36	36
Fracture	33	34
Material Twisted/Bent	32	32
Contamination /Decontamination Problem	29	29
Illegible Information	28	28
Chemical Problem	28	28
Mechanical Jam	19	19
Missing Information	16	16
Detachment of Device or Device Component	14	14
Difficult to Open or Close	14	14
Entrapment of Device	10	10
Crack	9	9
Device Contaminated During Manufacture or Shipping	7	7
Device Dislodged or Dislocated	6	6
Off-Label Use	4	4
Corroded	4	4
Tear, Rip or Hole in Device Packaging	3	3
Defective Device	2	2
Positioning Failure	2	2
Device Slipped	2	2
Improper or Incorrect Procedure or Method	2	2
Positioning Problem	1	1
Difficult to Remove	1	1
Separation Failure	1	1
Backflow	1	1
Use of Device Problem	1	1
Output Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Damaged by Another Device	1	1
Inadequacy of Device Shape and/or Size	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2039	2074
Insufficient Information	326	327
Limb Fracture	27	27
Unspecified Tissue Injury	14	14
Bone Fracture(s)	13	13
Joint Dislocation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Foreign Body In Patient	4	4
Joint Laxity	4	4
Unspecified Infection	3	3
Arthralgia	2	2
Pain	2	2
Deformity/ Disfigurement	2	2
Thrombosis/Thrombus	1	1
Nerve Damage	1	1
Scar Tissue	1	1
Distress	1	1