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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 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
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