TPLC - Total Product Life Cycle

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Device	nail, fixation, bone
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	JDS
Regulation Number	888.3030
Device Class	2

Premarket Reviews
Manufacturer	Decision
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
NARANG MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	4
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1154	1167
Device-Device Incompatibility	904	910
Break	553	562
Fracture	143	144
Migration	136	136
Material Deformation	104	105
Insufficient Device Problem Information	82	82
Manufacturing, Packaging or Shipping Problem	67	67
Material Twisted/Bent	54	54
Detachment of Device or Device Component	52	53
Migration or Expulsion of Device	33	34
Crack	25	25
Use of Device Problem	23	23
No Apparent Adverse Event	22	22
Material Integrity Problem	22	22
Device Slipped	20	20
Loose or Intermittent Connection	17	17
Difficult to Advance	17	17
Entrapment of Device	16	16
Improper or Incorrect Procedure or Method	15	15
Delivered as Unsterile Product	14	14
Loosening of Implant Not Related to Bone-Ingrowth	14	14
Failure to Align	12	12
Connection Problem	10	10
Defective Device	9	9
Appropriate Device Problem Term/Code Not Available	8	8
Device Dislodged or Dislocated	7	7
Naturally Worn	6	6
Illegible Information	6	6
Device Markings/Labelling Problem	6	6
Mechanical Jam	5	5
Device Contaminated During Manufacture or Shipping	5	5
Nonstandard Device	5	5
Malposition of Device	5	5
Tear, Rip or Hole in Device Packaging	5	5
Unsealed Device Packaging	4	4
Difficult to Insert	4	4
Positioning Failure	4	4
Missing Information	4	4
Component Missing	4	5
Scratched Material	3	3
Mechanical Problem	3	3
Packaging Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
Material Separation	3	3
Loss of Osseointegration	2	2
Deformation Due to Compressive Stress	2	2
Fitting Problem	2	2
Component Misassembled	2	2
Separation Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1344	1356
Nonunion/Delayed-union Bone Fracture	398	401
Insufficient Information	317	318
Failure of Implant	259	260
Injury	215	215
Unspecified Infection	204	212
No Code Available	203	203
Pain	167	169
Bone Fracture(s)	123	125
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	85	85
Physical Asymmetry	69	72
No Consequences Or Impact To Patient	64	64
Malunion of Bone	54	54
Deformity/ Disfigurement	53	54
Post Operative Wound Infection	49	49
Discomfort	39	39
Necrosis	38	38
Skin Inflammation/ Irritation	35	35
No Known Impact Or Consequence To Patient	35	35
Impaired Healing	31	31
Loss of Range of Motion	30	30
Thrombosis/Thrombus	26	26
Foreign Body In Patient	25	26
Implant Pain	22	23
Inflammation	20	20
Perforation	19	19
Unspecified Tissue Injury	17	17
Fall	16	16
Ambulation or Postural Difficulties	16	16
Nerve Damage	15	15
Hip Fracture	13	13
No Patient Involvement	13	13
Limb Fracture	12	12
Hematoma	12	12
Device Embedded In Tissue or Plaque	11	11
Tissue Damage	11	11
Swelling/ Edema	10	10
No Information	10	10
Bacterial Infection	9	9
Joint Dislocation	9	9
Extraskeletal ossification	8	9
Inadequate Osseointegration	8	8
Muscular Rigidity	8	8
Periprosthetic fracture	7	7
Fluid Discharge	7	7
Cellulitis	6	8
Muscle Weakness/Atrophy	6	6
Reaction	6	6
Medical device site infection	5	5
Skin Infection	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Orthopaedics GmbH	II	May-25-2022
2	Smith & Nephew, Inc.	II	Jan-06-2021
3	Smith & Nephew, Inc.	II	Jul-22-2020
4	Synthes (USA) Products LLC	II	Oct-21-2025