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
NARANG MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW 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	643	643
2021	630	630
2022	598	598
2023	357	357
2024	120	120

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1389	1389
Break	596	596
Device-Device Incompatibility	449	449
Insufficient Information	203	203
Fracture	186	186
Migration	113	113
Material Deformation	67	67
Manufacturing, Packaging or Shipping Problem	65	65
Migration or Expulsion of Device	63	63
Material Twisted/Bent	47	47
No Apparent Adverse Event	29	29
Detachment of Device or Device Component	27	27
Failure to Align	27	27
Loose or Intermittent Connection	27	27
Device Slipped	25	25
Appropriate Term/Code Not Available	24	24
Unintended Movement	22	22
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Entrapment of Device	21	21
Connection Problem	19	19
Device Operates Differently Than Expected	18	18
Use of Device Problem	18	18
Improper or Incorrect Procedure or Method	16	16
Crack	14	14
Difficult to Advance	13	13
Device Dislodged or Dislocated	12	12
Mechanical Jam	11	11
Material Integrity Problem	11	11
Patient-Device Incompatibility	9	9
Defective Device	9	9
Device Markings/Labelling Problem	8	8
Device Difficult to Maintain	8	8
Malposition of Device	7	7
Material Fragmentation	7	7
Component Missing	6	6
Naturally Worn	6	6
Patient Device Interaction Problem	6	6
Difficult to Insert	5	5
Mechanical Problem	5	5
Fitting Problem	5	5
Inadequacy of Device Shape and/or Size	4	4
Difficult to Remove	4	4
Nonstandard Device	4	4
Delivered as Unsterile Product	3	3
Material Separation	3	3
Bent	3	3
Device Damaged by Another Device	3	3
Device Handling Problem	3	3
Packaging Problem	3	3
Positioning 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
Contamination /Decontamination Problem	2	2
Device Operational Issue	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
Separation Failure	2	2
Activation, Positioning or Separation Problem	2	2
Loss of or Failure to Bond	2	2
Positioning Failure	2	2
Failure To Adhere Or Bond	2	2
Product Quality Problem	2	2
Shipping Damage or Problem	1	1
Device Damaged Prior to Use	1	1
Off-Label Use	1	1
Material Puncture/Hole	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Misassembled	1	1
Misconnection	1	1
Degraded	1	1
Disassembly	1	1
Material Discolored	1	1
Material Disintegration	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
Biocompatibility	1	1
Deformation Due to Compressive Stress	1	1
Difficult or Delayed Activation	1	1
Failure to Advance	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Osseointegration Problem	1	1
Material Split, Cut or Torn	1	1
Noise, Audible	1	1
Torn Material	1	1
Misassembly by Users	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	696	696
No Code Available	534	534
Non-union Bone Fracture	447	447
Injury	395	395
Failure of Implant	316	316
Unspecified Infection	288	288
Pain	244	244
No Consequences Or Impact To Patient	208	208
Bone Fracture(s)	164	164
Insufficient Information	112	112
No Known Impact Or Consequence To Patient	104	104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	85	85
Impaired Healing	76	76
Discomfort	60	60
Physical Asymmetry	56	56
Necrosis	54	54
Post Operative Wound Infection	49	49
No Information	46	46
Deformity/ Disfigurement	46	46
Foreign Body In Patient	45	45
Loss of Range of Motion	41	41
Malunion of Bone	38	38
No Patient Involvement	29	29
Skin Inflammation/ Irritation	27	27
Thrombosis/Thrombus	24	24
Inflammation	21	21
Perforation	19	19
Tissue Damage	19	19
Nerve Damage	16	16
Hip Fracture	15	15
Hypersensitivity/Allergic reaction	14	14
Fall	14	14
Ambulation Difficulties	14	14
Device Embedded In Tissue or Plaque	14	14
Not Applicable	14	14
Unspecified Tissue Injury	13	13
Hematoma	11	11
Joint Dislocation	10	10
Bacterial Infection	9	9
Ossification	8	8
Implant Pain	8	8
Limb Fracture	7	7
Swelling/ Edema	7	7
Cellulitis	7	7
Death	7	7
Reaction	7	7
Muscular Rigidity	7	7
Skin Irritation	7	7
Paralysis	5	5
Skin Infection	5	5
Inadequate Osseointegration	5	5
Unequal Limb Length	4	4
Joint Laxity	4	4
Muscle Weakness	4	4
Pulmonary Embolism	4	4
Abscess	4	4
Wound Dehiscence	3	3
Fever	3	3
Arthritis	3	3
Irritation	3	3
Swelling	3	3
Rash	3	3
Thrombosis	3	3
Hypoesthesia	3	3
Arthralgia	3	3
Fluid Discharge	3	3
Patient Problem/Medical Problem	2	2
Confusion/ Disorientation	2	2
Muscle/Tendon Damage	2	2
Osteomyelitis	2	2
Vertebral Fracture	2	2
Embolism/Embolus	2	2
Sedation	2	2
Numbness	2	2
Weakness	2	2
Pocket Erosion	2	2
Neuropathy	2	2
Hemorrhage/Bleeding	2	2
Anemia	2	2
Calcium Deposits/Calcification	2	2
Adhesion(s)	1	1
Abrasion	1	1
Fistula	1	1
Edema	1	1
Extravasation	1	1
Cyst(s)	1	1
Internal Organ Perforation	1	1
Neovascularization	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Hypoxia	1	1
Tingling	1	1
Therapeutic Response, Decreased	1	1
Ulcer	1	1
Urticaria	1	1
Scar Tissue	1	1
Sepsis	1	1
Skin Erosion	1	1
Synovitis	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