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	604	604

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1282	1282
Break	486	486
Device-Device Incompatibility	286	286
Insufficient Information	199	199
Fracture	166	166
Migration	88	88
Manufacturing, Packaging or Shipping Problem	63	63
Migration or Expulsion of Device	62	62
Material Deformation	48	48
Material Twisted/Bent	38	38
Loose or Intermittent Connection	27	27
No Apparent Adverse Event	26	26
Failure to Align	24	24
Appropriate Term/Code Not Available	23	23
Unintended Movement	22	22
Loosening of Implant Not Related to Bone-Ingrowth	20	20
Connection Problem	19	19
Device Operates Differently Than Expected	18	18
Entrapment of Device	17	17
Device Slipped	16	16
Detachment of Device or Device Component	16	16
Improper or Incorrect Procedure or Method	15	15
Device Dislodged or Dislocated	12	12
Use of Device Problem	12	12
Mechanical Jam	11	11
Patient-Device Incompatibility	9	9
Device Difficult to Maintain	8	8
Device Markings/Labelling Problem	7	7
Difficult to Advance	7	7
Malposition of Device	7	7
Material Fragmentation	7	7
Component Missing	6	6
Naturally Worn	6	6
Crack	6	6
Patient Device Interaction Problem	5	5
Fitting Problem	5	5
Difficult to Remove	4	4
Mechanical Problem	4	4
Nonstandard Device	4	4
Defective Device	4	4
Difficult to Insert	4	4
Delivered as Unsterile Product	3	3
Positioning Problem	3	3
Scratched Material	3	3
Packaging Problem	3	3
Material Separation	3	3
Device Damaged by Another Device	3	3
Bent	3	3
Material Integrity Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
Incomplete or Inadequate Connection	3	3
Physical Resistance/Sticking	2	2
Sticking	2	2
Unstable	2	2
Product Quality Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Loss of Osseointegration	2	2
Failure To Adhere Or Bond	2	2
Device Operational Issue	2	2
Incomplete or Missing Packaging	2	2
Separation Failure	2	2
Device Handling Problem	2	2
Loss of or Failure to Bond	2	2
Activation, Positioning or Separation Problem	2	2
Component Misassembled	2	2
Premature Separation	1	1
Thickening of Material	1	1
Difficult or Delayed Activation	1	1
Biocompatibility	1	1
Contamination /Decontamination Problem	1	1
Misassembled	1	1
Noise, Audible	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Difficult or Delayed Separation	1	1
Torn Material	1	1
Deformation Due to Compressive Stress	1	1
Material Puncture/Hole	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Shipping Damage or Problem	1	1
Degraded	1	1
Disassembly	1	1
Misassembly by Users	1	1
Component Incompatible	1	1
Positioning Failure	1	1
Material Disintegration	1	1
Off-Label Use	1	1
Detachment Of Device Component	1	1
Material Discolored	1	1
Misconnection	1	1
Failure to Advance	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Osseointegration Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	534	534
No Clinical Signs, Symptoms or Conditions	449	449
Non-union Bone Fracture	402	402
Injury	395	395
Failure of Implant	287	287
Unspecified Infection	256	256
Pain	211	211
No Consequences Or Impact To Patient	208	208
Bone Fracture(s)	158	158
No Known Impact Or Consequence To Patient	105	105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	88	88
Impaired Healing	71	71
Discomfort	59	59
Necrosis	53	53
Physical Asymmetry	50	50
No Information	46	46
Post Operative Wound Infection	43	43
Deformity/ Disfigurement	40	40
Foreign Body In Patient	39	39
Loss of Range of Motion	38	38
Malunion of Bone	35	35
Insufficient Information	31	31
No Patient Involvement	29	29
Thrombosis/Thrombus	23	23
Skin Inflammation/ Irritation	22	22
Tissue Damage	19	19
Perforation	19	19
Inflammation	17	17
Hip Fracture	16	16
Nerve Damage	15	15
Ambulation Difficulties	14	14
Hypersensitivity/Allergic reaction	14	14
Not Applicable	14	14
Device Embedded In Tissue or Plaque	12	12
Fall	10	10
Hematoma	10	10
Bacterial Infection	9	9
Joint Dislocation	9	9
Unspecified Tissue Injury	8	8
Death	7	7
Muscular Rigidity	7	7
Skin Irritation	7	7
Reaction	7	7
Limb Fracture	6	6
Ossification	6	6
Cellulitis	6	6
Implant Pain	5	5
Paralysis	5	5
Unequal Limb Length	4	4
Inadequate Osseointegration	4	4
Joint Laxity	4	4
Skin Infection	4	4
Pulmonary Embolism	4	4
Arthritis	3	3
Irritation	3	3
Fluid Discharge	3	3
Swelling	3	3
Thrombosis	3	3
Hypoesthesia	3	3
Swelling/ Edema	3	3
Rash	3	3
Abscess	3	3
Fever	3	3
Wound Dehiscence	2	2
Calcium Deposits/Calcification	2	2
Muscle Weakness	2	2
Neuropathy	2	2
Numbness	2	2
Muscle/Tendon Damage	2	2
Vertebral Fracture	2	2
Pocket Erosion	2	2
Weakness	2	2
Patient Problem/Medical Problem	2	2
Confusion/ Disorientation	2	2
Arthralgia	2	2
Sedation	2	2
Embolism/Embolus	2	2
Osteomyelitis	2	2
Skin Erosion	1	1
Osteolysis	1	1
Low Oxygen Saturation	1	1
Cyst(s)	1	1
Abrasion	1	1
Disability	1	1
Bronchopneumonia	1	1
Tingling	1	1
Therapeutic Response, Decreased	1	1
Internal Organ Perforation	1	1
Edema	1	1
Hemorrhage/Bleeding	1	1
Hypoxia	1	1
Damage to Ligament(s)	1	1
Electric Shock	1	1
Pseudoaneurysm	1	1
Movement Disorder	1	1
Skin Disorders	1	1
Urticaria	1	1
Adhesion(s)	1	1
Ventilator Dependent	1	1
Scar Tissue	1	1

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	Smith & Nephew, Inc.	II	Nov-16-2017
5	Zimmer Biomet, Inc.	II	Mar-27-2017