TPLC - Total Product Life Cycle

• Device: suture, surgical, absorbable, polydioxanone
• Product Code: NEW
• Regulation Number: 878.4840
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DEMETECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	3
FEELTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MEDITIME CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OV WORLD CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	900	900
2019	1122	1122
2020	1010	1010
2021	1464	1830
2022	1537	2757
2023	1662	1662

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4271	5003
Material Separation	1419	1419
Adverse Event Without Identified Device or Use Problem	1012	1256
Material Integrity Problem	258	258
Detachment of Device or Device Component	131	375
Positioning Failure	130	130
Patient Device Interaction Problem	93	215
Detachment Of Device Component	92	92
Appropriate Term/Code Not Available	69	69
Material Frayed	66	66
Migration	63	63
Positioning Problem	59	59
Device Markings/Labelling Problem	40	40
Tear, Rip or Hole in Device Packaging	38	38
Insufficient Information	37	37
Material Protrusion/Extrusion	36	158
Defective Component	34	34
Component Misassembled	31	31
Material Split, Cut or Torn	30	30
Device Operates Differently Than Expected	28	28
Migration or Expulsion of Device	25	25
Material Twisted/Bent	24	146
Device Contaminated During Manufacture or Shipping	17	17
Patient-Device Incompatibility	16	16
Failure To Adhere Or Bond	16	16
Delivered as Unsterile Product	15	15
Manufacturing, Packaging or Shipping Problem	13	13
Component Incompatible	12	12
Difficult to Open or Remove Packaging Material	11	11
Expulsion	11	11
Loss of or Failure to Bond	10	10
Device Appears to Trigger Rejection	9	9
Component Missing	8	8
Device Fell	8	8
Inadequacy of Device Shape and/or Size	7	7
Material Discolored	6	6
Entrapment of Device	6	6
Failure to Form Staple	5	5
Leak/Splash	4	4
Loose or Intermittent Connection	4	4
Degraded	4	4
Material Fragmentation	4	4
Product Quality Problem	3	3
Material Rupture	3	3
Use of Device Problem	3	3
Material Erosion	3	3
Fracture	3	125
Out-Of-Box Failure	3	3
Dull, Blunt	3	3
Material Deformation	3	3
Packaging Problem	3	3
Separation Failure	2	2
Incorrect Device Or Component Shipped	2	2
Device Dislodged or Dislocated	2	2
Incomplete or Missing Packaging	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Improper or Incorrect Procedure or Method	2	2
Device Slipped	2	2
Air Leak	2	2
Nonstandard Device	2	2
Difficult to Remove	2	2
Unsealed Device Packaging	2	2
No Apparent Adverse Event	2	2
Noise, Audible	2	124
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Separation Problem	1	1
Missing Information	1	1
Peeled/Delaminated	1	1
Inadequate or Insufficient Training	1	1
Material Disintegration	1	1
Mechanical Problem	1	1
Melted	1	1
Difficult or Delayed Positioning	1	1
Contamination	1	1
Crack	1	1
Contamination of Device Ingredient or Reagent	1	1
Defective Device	1	1
Malposition of Device	1	1
Microbial Contamination of Device	1	1
Device Issue	1	1
Cut In Material	1	1
Dent in Material	1	1
Difficult to Open or Close	1	1
Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3742	4230
No Consequences Or Impact To Patient	2157	2157
Wound Dehiscence	519	763
Not Applicable	384	384
Unspecified Infection	330	452
Pain	185	185
Insufficient Information	147	269
No Code Available	138	138
Post Operative Wound Infection	107	229
Inflammation	102	102
Hemorrhage/Bleeding	100	101
Hernia	97	97
Abscess	96	96
Hematoma	93	93
Failure to Anastomose	92	92
Fistula	84	84
No Known Impact Or Consequence To Patient	75	75
Foreign Body In Patient	69	313
Seroma	59	59
Obstruction/Occlusion	58	58
Discomfort	57	57
Erythema	52	52
Fluid Discharge	51	173
Unspecified Tissue Injury	49	49
Impaired Healing	46	168
Pocket Erosion	44	44
Hypersensitivity/Allergic reaction	43	43
Purulent Discharge	43	43
Swelling/ Edema	43	43
Necrosis	42	42
Blood Loss	42	42
Skin Inflammation/ Irritation	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	39	161
Fever	37	37
Foreign Body Reaction	35	35
Scar Tissue	31	31
Sepsis	30	31
Urinary Tract Infection	26	26
Granuloma	24	24
Incontinence	24	24
Nodule	21	21
Rupture	20	20
Swelling	19	19
Local Reaction	18	18
Itching Sensation	17	17
Ulcer	15	15
Joint Dislocation	15	15
Urinary Retention	14	14
Adhesion(s)	14	14
Erosion	12	12
Nausea	11	11
Pleural Effusion	10	10
Abdominal Pain	10	10
Cellulitis	10	10
Device Embedded In Tissue or Plaque	10	10
Thrombosis/Thrombus	10	10
No Patient Involvement	9	9
Paresis	9	9
Pneumonia	8	8
Loss of Range of Motion	7	7
Death	7	7
Skin Irritation	7	7
Vomiting	7	7
Bacterial Infection	6	6
Pneumothorax	6	6
Perforation	5	5
Ischemia	5	5
Bruise/Contusion	5	5
Dysphagia/ Odynophagia	5	5
Peritonitis	5	5
Thrombosis	5	5
Abdominal Distention	5	5
Needle Stick/Puncture	5	5
Blister	5	5
Muscle/Tendon Damage	5	5
Respiratory Failure	4	4
Injury	4	4
Abnormal Vaginal Discharge	4	4
Dizziness	4	4
Micturition Urgency	4	4
Rash	4	4
Muscular Rigidity	4	4
Myocardial Infarction	3	3
Damage to Ligament(s)	3	3
Nerve Damage	3	3
Failure of Implant	3	125
Diarrhea	3	3
Edema	3	3
Calcium Deposits/Calcification	3	3
Anemia	3	3
Deformity/ Disfigurement	3	3
Stenosis	3	3
Tissue Damage	3	3
Septic Shock	3	3
Neck Pain	3	3
No Information	3	3
Breast Discomfort/Pain	3	3
Restenosis	2	2
Respiratory Tract Infection	2	2
Reaction	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ethicon, Inc.	II	May-10-2023
2	Ethicon, Inc.	II	Dec-14-2022
3	Ethicon, Inc.	II	Sep-20-2022
4	Ethicon, Inc.	II	Feb-06-2020
5	Ethicon, Inc.	II	Oct-04-2019
6	Ethicon, Inc.	II	Apr-12-2019
7	Ethicon, Inc.	II	Jul-24-2018
8	Ethicon, Inc.	II	Apr-10-2018