TPLC - Total Product Life Cycle

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Device	blade, saw, general & plastic surgery, surgical
Product Code	GFA
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	788	881
Break	547	547
Material Fragmentation	234	234
Mechanical Jam	157	157
Complete Loss of Power	113	113
Tear, Rip or Hole in Device Packaging	52	52
Delivered as Unsterile Product	51	63
Dull, Blunt	32	32
Device Contaminated During Manufacture or Shipping	28	28
Failure to Cut	27	27
Excessive Heating	25	25
Detachment of Device or Device Component	24	24
Packaging Problem	20	20
Appropriate Term/Code Not Available	19	19
Overheating of Device	19	19
Contamination /Decontamination Problem	18	18
Defective Device	14	14
Entrapment of Device	14	14
Material Separation	12	12
Material Integrity Problem	12	12
Separation Problem	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Material Twisted/Bent	9	9
Smoking	8	8
Contamination	8	8
Physical Resistance/Sticking	7	7
Insufficient Cooling	7	7
Material Disintegration	7	8
Loose or Intermittent Connection	7	7
No Apparent Adverse Event	7	7
Material Deformation	6	6
Insufficient Information	6	6
Device-Device Incompatibility	6	6
Output Problem	5	5
Fitting Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Use of Device Problem	5	5
Mechanical Problem	5	5
Continuous Firing	5	5
Temperature Problem	4	4
Device Slipped	4	4
Activation Failure	4	4
Patient Device Interaction Problem	4	4
Expiration Date Error	4	4
Melted	4	4
Vibration	4	4
Power Problem	3	3
Material Discolored	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Power Up	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1467	1573
No Consequences Or Impact To Patient	247	247
Insufficient Information	187	197
No Known Impact Or Consequence To Patient	144	144
No Patient Involvement	96	96
Foreign Body In Patient	81	81
Device Embedded In Tissue or Plaque	20	28
Burn(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
No Code Available	7	7
Superficial (First Degree) Burn	6	6
No Information	6	6
Laceration(s)	6	6
Pain	6	6
Not Applicable	5	5
Unspecified Infection	4	4
Unspecified Tissue Injury	4	4
Burn, Thermal	3	3
Tissue Damage	3	3
Hemorrhage/Bleeding	3	3
Patient Problem/Medical Problem	2	2
Bone Fracture(s)	2	2
Injury	2	2
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Limited Mobility Of The Implanted Joint	1	1
Abrasion	1	1
Purulent Discharge	1	1
Edema	1	1
Skin Discoloration	1	1
Swelling	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Perforation of Vessels	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-11-2023
2	Stryker Instruments Div. of Stryker Corporation	II	Apr-24-2019
3	Synvasive Technology Inc	II	Apr-06-2020