TPLC - Total Product Life Cycle

• Device: nail, fixation, bone
• 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
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	287	287
2018	320	320
2019	490	490
2020	644	644
2021	638	638
2022	245	245

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1122	1122
Break	429	429
Device-Device Incompatibility	244	244
Insufficient Information	199	199
Fracture	136	136
Migration	72	72
Manufacturing, Packaging or Shipping Problem	63	63
Migration or Expulsion of Device	57	57
Material Deformation	38	38
Material Twisted/Bent	29	29
Loose or Intermittent Connection	27	27
No Apparent Adverse Event	26	26
Failure to Align	23	23
Appropriate Term/Code Not Available	22	22
Unintended Movement	22	22
Connection Problem	19	19
Device Operates Differently Than Expected	18	18
Entrapment of Device	16	16
Loosening of Implant Not Related to Bone-Ingrowth	16	16
Device Slipped	14	14
Detachment of Device or Device Component	13	13
Device Dislodged or Dislocated	12	12
Improper or Incorrect Procedure or Method	12	12
Mechanical Jam	10	10
Use of Device Problem	10	10
Patient-Device Incompatibility	9	9
Device Difficult to Maintain	8	8
Naturally Worn	6	6
Material Fragmentation	6	6
Crack	5	5
Fitting Problem	5	5
Patient Device Interaction Problem	5	5
Component Missing	4	4
Mechanical Problem	4	4
Defective Device	4	4
Device Markings/Labelling Problem	4	4
Difficult to Advance	3	3
Malposition of Device	3	3
Packaging Problem	3	3
Scratched Material	3	3
Difficult to Insert	3	3
Bent	3	3
Nonstandard Device	3	3
Difficult to Remove	3	3
Material Separation	3	3
Inadequacy of Device Shape and/or Size	3	3
Incomplete or Inadequate Connection	3	3
Physical Resistance/Sticking	2	2
Product Quality Problem	2	2
Incomplete or Missing Packaging	2	2
Tear, Rip or Hole in Device Packaging	2	2
Loss of Osseointegration	2	2
Sticking	2	2
Unstable	2	2
Loss of or Failure to Bond	2	2
Failure To Adhere Or Bond	2	2
Device Handling Problem	2	2
Positioning Problem	2	2
Separation Failure	2	2
Activation, Positioning or SeparationProblem	2	2
Device Operational Issue	2	2
Device Damaged by Another Device	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination /Decontamination Problem	1	1
Difficult or Delayed Activation	1	1
Osseointegration Problem	1	1
Material Integrity Problem	1	1
Noise, Audible	1	1
Torn Material	1	1
Misassembly by Users	1	1
Misassembled	1	1
Misconnection	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
Degraded	1	1
Disassembly	1	1
Material Discolored	1	1
Material Disintegration	1	1
Failure to Advance	1	1
Shipping Damage or Problem	1	1
Incorrect, Inadequate or Imprecise Resultor Readings	1	1
Delivered as Unsterile Product	1	1
Material Puncture/Hole	1	1
Component Misassembled	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Thickening of Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	534	534
Injury	395	395
Non-union Bone Fracture	350	350
No Clinical Signs, Symptoms or Conditions	321	321
Failure of Implant	239	239
Unspecified Infection	224	224
No Consequences Or Impact To Patient	208	208
Pain	189	189
Bone Fracture(s)	130	130
No Known Impact Or Consequence To Patient	105	105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	79	79
Impaired Healing	67	67
Necrosis	47	47
Discomfort	47	47
No Information	46	46
Physical Asymmetry	44	44
Post Operative Wound Infection	38	38
Foreign Body In Patient	35	35
No Patient Involvement	29	29
Loss of Range of Motion	29	29
Malunion of Bone	27	27
Skin Inflammation/ Irritation	21	21
Tissue Damage	19	19
Deformity/ Disfigurement	19	19
Thrombosis/Thrombus	17	17
Insufficient Information	16	16
Not Applicable	14	14
Hypersensitivity/Allergic reaction	13	13
Nerve Damage	12	12
Ambulation Difficulties	12	12
Hip Fracture	11	11
Device Embedded In Tissue or Plaque	11	11
Joint Dislocation	9	9
Perforation	8	8
Hematoma	8	8
Fall	8	8
Bacterial Infection	8	8
Unspecified Tissue Injury	8	8
Death	7	7
Inflammation	7	7
Muscular Rigidity	7	7
Skin Irritation	7	7
Reaction	7	7
Paralysis	5	5
Ossification	5	5
Implant Pain	4	4
Skin Infection	4	4
Joint Laxity	4	4
Limb Fracture	4	4
Inadequate Osseointegration	3	3
Pulmonary Embolism	3	3
Abscess	3	3
Arthritis	3	3
Cellulitis	3	3
Fever	3	3
Rash	3	3
Irritation	3	3
Swelling	3	3
Thrombosis	3	3
Hypoesthesia	3	3
Pocket Erosion	2	2
Numbness	2	2
Confusion/ Disorientation	2	2
Sedation	2	2
Weakness	2	2
Neuropathy	2	2
Wound Dehiscence	2	2
Patient Problem/Medical Problem	2	2
Vertebral Fracture	2	2
Unequal Limb Length	2	2
Swelling/ Edema	2	2
Muscle/Tendon Damage	1	1
Osteomyelitis	1	1
Movement Disorder	1	1
Embolism/Embolus	1	1
Low Oxygen Saturation	1	1
Osteopenia/ Osteoporosis	1	1
Intraoperative Pain	1	1
Fluid Discharge	1	1
Calcium Deposits/Calcification	1	1
Adhesion(s)	1	1
Abrasion	1	1
Hemorrhage/Bleeding	1	1
Cyst(s)	1	1
Edema	1	1
Scar Tissue	1	1
Skin Erosion	1	1
Itching Sensation	1	1
Damage to Ligament(s)	1	1
Muscle Weakness	1	1
Hypoxia	1	1
Neovascularization	1	1
Tingling	1	1
Osteolysis	1	1
Disability	1	1
Electric Shock	1	1
Pseudoaneurysm	1	1
Bronchopneumonia	1	1
Ventilator Dependent	1	1
Tachycardia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew, Inc.	II	Jan-06-2021
2	Smith & Nephew, Inc.	II	Jul-22-2020
3	Smith & Nephew, Inc.	II	Nov-16-2017
4	Zimmer Biomet, Inc.	II	Mar-27-2017