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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nail, fixation, bone
Product CodeJDS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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