TPLC - Total Product Life Cycle

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Device	blade, saw, general & plastic surgery, surgical
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	GFA
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	870	1088
Break	402	403
Material Fragmentation	329	329
Mechanical Jam	193	193
Complete Loss of Power	135	135
Delivered as Unsterile Product	75	98
Smoking	51	51
Dull, Blunt	43	43
Overheating of Device	28	28
Excessive Heating	27	27
Appropriate Term/Code Not Available	26	26
Device Contaminated During Manufacture or Shipping	26	26
Failure to Cut	26	26
Tear, Rip or Hole in Device Packaging	24	24
Detachment of Device or Device Component	22	22
Defective Device	16	16
Entrapment of Device	14	14
Packaging Problem	14	14
Separation Problem	12	12
Material Integrity Problem	12	12
Contamination /Decontamination Problem	12	12
Material Separation	11	11
Physical Resistance/Sticking	11	11
Material Twisted/Bent	11	11
Insufficient Information	8	8
Device-Device Incompatibility	8	8
Use of Device Problem	8	8
No Apparent Adverse Event	8	8
Contamination	8	8
Insufficient Cooling	7	7
Material Deformation	7	7
Loose or Intermittent Connection	6	6
Material Disintegration	6	7
Adverse Event Without Identified Device or Use Problem	6	6
Output Problem	5	5
Premature Separation	5	5
Continuous Firing	5	5
Device Contamination with Chemical or Other Material	5	5
Unsealed Device Packaging	5	5
Fitting Problem	5	5
Activation Failure	4	4
Patient Device Interaction Problem	4	4
Expiration Date Error	4	4
Mechanical Problem	4	4
Device Slipped	4	4
Material Discolored	3	3
Unintended Ejection	3	3
Nonstandard Device	3	3
Improper or Incorrect Procedure or Method	3	3
Temperature Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1927	2169
Insufficient Information	228	258
No Consequences Or Impact To Patient	102	102
Foreign Body In Patient	92	92
No Patient Involvement	41	41
No Known Impact Or Consequence To Patient	36	36
Device Embedded In Tissue or Plaque	19	30
Burn(s)	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pain	7	7
Laceration(s)	6	6
Superficial (First Degree) Burn	5	5
Bone Fracture(s)	5	5
Unspecified Tissue Injury	4	4
Unspecified Infection	3	3
No Code Available	3	3
No Information	3	3
Hemorrhage/Bleeding	3	3
Muscle Weakness	2	2
Burn, Thermal	2	2
Anxiety	2	2
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Injury	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Extravasation	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	Synvasive Technology Inc	II	Apr-06-2020