TPLC - Total Product Life Cycle

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Device	punch, surgical
Regulation Description	Manual surgical instrument for general use.
Product Code	LRY
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	60
Material Twisted/Bent	32	32
Packaging Problem	29	30
Device-Device Incompatibility	24	24
Contamination /Decontamination Problem	20	20
Dull, Blunt	20	29
Material Deformation	18	18
Failure to Cut	12	13
Naturally Worn	12	12
Physical Resistance/Sticking	12	12
Material Integrity Problem	11	11
Mechanical Problem	11	12
Material Fragmentation	9	9
Mechanical Jam	7	7
Compatibility Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Material Too Soft/Flexible	3	3
Sharp Edges	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Off-Label Use	2	2
Fracture	2	2
Unintended Movement	2	2
Use of Device Problem	2	2
Crack	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Component Missing	1	1
Detachment of Device or Device Component	1	1
Difficult to Remove	1	1
No Apparent Adverse Event	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1
Degraded	1	1
Difficult or Delayed Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	234	236
Insufficient Information	19	19
Perforation of Vessels	12	21
Unspecified Tissue Injury	3	3
Laceration(s)	3	3
Hemorrhage/Blood Loss/Bleeding	1	1
Abrasion	1	1
Needle Stick/Puncture	1	1
Impaired Healing	1	1
Hypersensitivity/Allergic reaction	1	1
Inflammation	1	1
Osteopenia/ Osteoporosis	1	1
Swelling/ Edema	1	1
Pain	1	1
Skin Tears	1	1
Intraoperative Pain	1	1
Great Vessel Perforation	1	1