TPLC - Total Product Life Cycle

show TPLC since

Device	passer
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWQ
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	347	349
Detachment of Device or Device Component	56	56
Material Separation	42	42
Mechanical Jam	26	26
Mechanical Problem	18	18
Material Fragmentation	16	16
Material Deformation	14	14
Physical Resistance/Sticking	13	13
Fracture	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Firing Problem	7	7
Difficult to Open or Close	7	7
Insufficient Information	7	8
Material Integrity Problem	7	7
Material Split, Cut or Torn	5	5
Misassembled	5	5
Failure to Cycle	4	4
Device Dislodged or Dislocated	4	4
No Apparent Adverse Event	4	5
Ejection Problem	4	4
Device-Device Incompatibility	3	3
Flaked	3	3
Nonstandard Device	3	3
Device Damaged Prior to Use	3	3
Device Fell	3	3
Expiration Date Error	3	3
Failure to Fire	3	3
Failure to Advance	2	2
Activation Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Unstable	2	2
Material Twisted/Bent	1	1
Problem with Sterilization	1	1
Component Missing	1	1
Use of Device Problem	1	1
Delivered as Unsterile Product	1	1
Solder Joint Fracture	1	1
Positioning Failure	1	1
Failure to Capture	1	1
Retraction Problem	1	1
Difficult to Insert	1	1
Difficult to Remove	1	1
Defective Device	1	1
Unsealed Device Packaging	1	1
Migration	1	1
Unintended Movement	1	1
Difficult to Fold, Unfold or Collapse	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	431	434
No Known Impact Or Consequence To Patient	91	92
No Consequences Or Impact To Patient	27	27
Foreign Body In Patient	19	19
No Information	12	12
Insufficient Information	7	7
No Patient Involvement	6	6
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hypersensitivity/Allergic reaction	2	2
Cardiac Arrest	2	2
Hemorrhage/Bleeding	2	2
Unspecified Infection	1	1
Failure of Implant	1	1
Perforation	1	1
Rupture	1	1
Chills	1	1
Loss of Range of Motion	1	1
Laceration(s)	1	1