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	791	884
Break	551	551
Material Fragmentation	244	244
Mechanical Jam	161	161
Complete Loss of Power	117	117
Delivered as Unsterile Product	54	66
Tear, Rip or Hole in Device Packaging	52	52
Dull, Blunt	32	32
Device Contaminated During Manufacture or Shipping	31	31
Failure to Cut	27	27
Excessive Heating	25	25
Detachment of Device or Device Component	24	24
Overheating of Device	20	20
Packaging Problem	20	20
Appropriate Term/Code Not Available	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
Physical Resistance/Sticking	8	8
Smoking	8	8
Contamination	8	8
Insufficient Cooling	7	7
Material Disintegration	7	8
Loose or Intermittent Connection	7	7
No Apparent Adverse Event	7	7
Insufficient Information	6	6
Material Deformation	6	6
Fitting Problem	6	6
Device-Device Incompatibility	6	6
Device Contamination with Chemical or Other Material	5	5
Use of Device Problem	5	5
Mechanical Problem	5	5
Continuous Firing	5	5
Output Problem	5	5
Temperature Problem	4	4
Expiration Date Error	4	4
Activation Failure	4	4
Patient Device Interaction Problem	4	4
Melted	4	4
Vibration	4	4
Device Slipped	4	4
Component Missing	3	3
Peeled/Delaminated	3	3
Failure to Power Up	3	3
Nonstandard Device	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1496	1602
No Consequences Or Impact To Patient	247	247
Insufficient Information	190	200
No Known Impact Or Consequence To Patient	144	144
No Patient Involvement	96	96
Foreign Body In Patient	85	85
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