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
2018	320	320
2019	490	490
2020	644	644
2021	638	638
2022	609	609
2023	143	143

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1182	1182
Break	442	442
Device-Device Incompatibility	338	338
Insufficient Information	177	177
Fracture	151	151
Migration	98	98
Manufacturing, Packaging or Shipping Problem	64	64
Migration or Expulsion of Device	53	53
Material Deformation	50	50
Material Twisted/Bent	39	39
No Apparent Adverse Event	28	28
Loose or Intermittent Connection	27	27
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Appropriate Term/Code Not Available	20	20
Detachment of Device or Device Component	20	20
Connection Problem	19	19
Failure to Align	18	18
Entrapment of Device	18	18
Device Slipped	17	17
Use of Device Problem	15	15
Improper or Incorrect Procedure or Method	15	15
Device Operates Differently Than Expected	12	12
Unintended Movement	10	10
Difficult to Advance	9	9
Device Dislodged or Dislocated	9	9
Mechanical Jam	8	8
Patient-Device Incompatibility	8	8
Device Difficult to Maintain	8	8
Crack	7	7
Device Markings/Labelling Problem	6	6
Defective Device	6	6
Naturally Worn	6	6
Malposition of Device	5	5
Difficult to Insert	5	5
Component Missing	5	5
Patient Device Interaction Problem	5	5
Nonstandard Device	4	4
Material Integrity Problem	4	4
Device Damaged by Another Device	3	3
Packaging Problem	3	3
Fitting Problem	3	3
Delivered as Unsterile Product	3	3
Material Separation	3	3
Bent	3	3
Mechanical Problem	3	3
Scratched Material	3	3
Incomplete or Inadequate Connection	3	3
Separation Problem	2	2
Physical Resistance/Sticking	2	2
Component Misassembled	2	2
Device Handling Problem	2	2
Material Fragmentation	2	2
Loss of or Failure to Bond	2	2
Product Quality Problem	2	2
Difficult to Remove	2	2
Incomplete or Missing Packaging	2	2
Tear, Rip or Hole in Device Packaging	2	2
Loss of Osseointegration	2	2
Inadequacy of Device Shape and/or Size	2	2
Sticking	2	2
Unstable	2	2
Device Operational Issue	2	2
Activation, Positioning or Separation Problem	2	2
Positioning Problem	2	2
Contamination /Decontamination Problem	2	2
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Misassembly by Users	1	1
Osseointegration Problem	1	1
Biocompatibility	1	1
Deformation Due to Compressive Stress	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Failure to Advance	1	1
Separation Failure	1	1
Difficult or Delayed Activation	1	1
Shipping Damage or Problem	1	1
Off-Label Use	1	1
Material Puncture/Hole	1	1
Component Incompatible	1	1
Degraded	1	1
Positioning Failure	1	1
Material Discolored	1	1
Material Disintegration	1	1
Failure To Adhere Or Bond	1	1
Misassembled	1	1
Noise, Audible	1	1
Material Split, Cut or Torn	1	1
Difficult or Delayed Separation	1	1
Premature Separation	1	1
Thickening of Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	530	530
No Code Available	432	432
Injury	375	375
Non-union Bone Fracture	342	342
Failure of Implant	242	242
Unspecified Infection	231	231
No Consequences Or Impact To Patient	208	208
Pain	188	188
Bone Fracture(s)	146	146
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	88	88
No Known Impact Or Consequence To Patient	81	81
Impaired Healing	62	62
Physical Asymmetry	54	54
Discomfort	49	49
Post Operative Wound Infection	46	46
Necrosis	46	46
Deformity/ Disfigurement	42	42
Insufficient Information	39	39
No Information	38	38
Malunion of Bone	37	37
Foreign Body In Patient	37	37
Loss of Range of Motion	34	34
No Patient Involvement	28	28
Skin Inflammation/ Irritation	26	26
Thrombosis/Thrombus	23	23
Inflammation	20	20
Tissue Damage	19	19
Perforation	18	18
Nerve Damage	16	16
Hip Fracture	16	16
Hypersensitivity/Allergic reaction	14	14
Ambulation Difficulties	13	13
Not Applicable	12	12
Joint Dislocation	11	11
Unspecified Tissue Injury	10	10
Hematoma	9	9
Bacterial Infection	9	9
Fall	8	8
Skin Irritation	7	7
Muscular Rigidity	7	7
Reaction	7	7
Swelling/ Edema	7	7
Limb Fracture	6	6
Device Embedded In Tissue or Plaque	6	6
Cellulitis	6	6
Ossification	6	6
Inadequate Osseointegration	5	5
Implant Pain	5	5
Skin Infection	4	4
Unequal Limb Length	4	4
Joint Laxity	4	4
Paralysis	4	4
Rash	3	3
Abscess	3	3
Arthritis	3	3
Irritation	3	3
Thrombosis	3	3
Hypoesthesia	3	3
Fluid Discharge	3	3
Vertebral Fracture	2	2
Embolism/Embolus	2	2
Muscle/Tendon Damage	2	2
Osteomyelitis	2	2
Arthralgia	2	2
Swelling	2	2
Weakness	2	2
Numbness	2	2
Confusion/ Disorientation	2	2
Fever	2	2
Wound Dehiscence	2	2
Calcium Deposits/Calcification	2	2
Pulmonary Embolism	2	2
Pocket Erosion	2	2
Hemorrhage/Bleeding	2	2
Muscle Weakness	2	2
Neuropathy	2	2
Internal Organ Perforation	1	1
Neovascularization	1	1
Scar Tissue	1	1
Skin Erosion	1	1
Abrasion	1	1
Adhesion(s)	1	1
Death	1	1
Extravasation	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Electric Shock	1	1
Bronchopneumonia	1	1
Osteopenia/ Osteoporosis	1	1
Intraoperative Pain	1	1
Patient Problem/Medical Problem	1	1
Ulcer	1	1
Urticaria	1	1
Therapeutic Effects, Unexpected	1	1
Osteolysis	1	1
Skin Disorders	1	1
Joint Contracture	1	1
Hyperextension	1	1
Movement Disorder	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