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	609	609
2023	52	52

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1306	1306
Break	495	495
Device-Device Incompatibility	302	302
Insufficient Information	199	199
Fracture	169	169
Migration	90	90
Manufacturing, Packaging or Shipping Problem	63	63
Migration or Expulsion of Device	62	62
Material Deformation	49	49
Material Twisted/Bent	39	39
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	21	21
Connection Problem	19	19
Device Slipped	18	18
Detachment of Device or Device Component	18	18
Device Operates Differently Than Expected	18	18
Entrapment of Device	17	17
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
Material Integrity Problem	4	4
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
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	476	476
Non-union Bone Fracture	411	411
Injury	395	395
Failure of Implant	292	292
Unspecified Infection	258	258
Pain	218	218
No Consequences Or Impact To Patient	208	208
Bone Fracture(s)	161	161
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	54	54
Physical Asymmetry	51	51
No Information	46	46
Post Operative Wound Infection	45	45
Deformity/ Disfigurement	42	42
Foreign Body In Patient	39	39
Loss of Range of Motion	39	39
Malunion of Bone	35	35
Insufficient Information	34	34
No Patient Involvement	29	29
Skin Inflammation/ Irritation	26	26
Thrombosis/Thrombus	23	23
Inflammation	19	19
Tissue Damage	19	19
Perforation	19	19
Hip Fracture	17	17
Nerve Damage	16	16
Ambulation Difficulties	14	14
Not Applicable	14	14
Hypersensitivity/Allergic reaction	14	14
Device Embedded In Tissue or Plaque	12	12
Fall	11	11
Hematoma	10	10
Joint Dislocation	10	10
Unspecified Tissue Injury	9	9
Bacterial Infection	9	9
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
Inadequate Osseointegration	5	5
Unequal Limb Length	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
Hemorrhage/Bleeding	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
Hypoxia	1	1
Damage to Ligament(s)	1	1
Edema	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