TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	2
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
HYUNDAE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUTURION AB
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1010	1010
2021	1464	1830
2022	1537	2757
2023	1975	1975
2024	2117	2117
2025	175	175

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4322	5054
Material Separation	1827	1827
Adverse Event Without Identified Device or Use Problem	1167	1411
Material Integrity Problem	287	287
Positioning Failure	236	236
Detachment of Device or Device Component	123	367
Patient Device Interaction Problem	115	237
Migration	68	68
Defective Component	66	66
Material Frayed	64	64
Device Markings/Labelling Problem	46	46
Delivered as Unsterile Product	46	46
Component Misassembled	44	44
Material Twisted/Bent	38	160
Material Protrusion/Extrusion	34	156
Material Split, Cut or Torn	31	31
Separation Problem	29	29
Device Contaminated During Manufacture or Shipping	24	24
Positioning Problem	22	22
Migration or Expulsion of Device	20	20
Difficult to Open or Remove Packaging Material	18	18
Manufacturing, Packaging or Shipping Problem	18	18
Appropriate Term/Code Not Available	18	18
Tear, Rip or Hole in Device Packaging	15	15
Device Appears to Trigger Rejection	14	14
Expulsion	12	12
Component Missing	9	9
Dull, Blunt	7	7
Packaging Problem	7	7
Insufficient Information	7	7
Device Fell	6	6
Material Fragmentation	6	6
Material Discolored	6	6
Difficult or Delayed Positioning	5	5
Patient-Device Incompatibility	4	4
Entrapment of Device	4	4
Material Deformation	4	4
Separation Failure	4	4
Inadequacy of Device Shape and/or Size	4	4
Use of Device Problem	3	3
Product Quality Problem	3	3
Material Rupture	2	2
Incomplete or Missing Packaging	2	2
Device Slipped	2	2
Loose or Intermittent Connection	2	2
Crack	2	2
Degraded	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Difficult or Delayed Separation	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5792	6280
No Consequences Or Impact To Patient	678	678
Wound Dehiscence	562	806
Unspecified Infection	370	492
Insufficient Information	272	394
Pain	173	173
Hemorrhage/Bleeding	143	143
Hernia	108	108
Inflammation	99	99
Failure to Anastomose	92	92
Foreign Body In Patient	90	334
Hematoma	90	90
Fistula	86	86
Abscess	84	84
Post Operative Wound Infection	81	203
Not Applicable	80	80
Impaired Healing	80	202
Fluid Discharge	68	190
Obstruction/Occlusion	68	68
Necrosis	65	65
Swelling/ Edema	65	65
Discomfort	63	63
Unspecified Tissue Injury	63	63
Pocket Erosion	63	63
Seroma	60	60
Erythema	60	60
Purulent Discharge	55	55
Hypersensitivity/Allergic reaction	50	50
Skin Inflammation/ Irritation	49	49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	167
Nodule	41	41
Scar Tissue	35	35
Fever	33	33
Sepsis	30	30
No Code Available	29	29
Granuloma	28	28
Foreign Body Reaction	25	25
Itching Sensation	23	23
Urinary Tract Infection	23	23
Joint Dislocation	21	21
Incontinence	20	20
Rupture	20	20
Ulcer	19	19
Blood Loss	18	18
Local Reaction	17	17
No Known Impact Or Consequence To Patient	17	17
Cellulitis	16	16
Thrombosis/Thrombus	13	13
Pleural Effusion	12	12
Urinary Retention	12	12

Recalls
Manufacturer		Recall Class	Date Posted
1	ETHICON, LLC	II	Sep-30-2024
2	Ethicon, Inc.	II	Jun-14-2024
3	Ethicon, Inc.	II	May-10-2023
4	Ethicon, Inc.	II	Dec-14-2022
5	Ethicon, Inc.	II	Sep-20-2022
6	Ethicon, Inc.	II	Feb-06-2020