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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pin, fixation, smooth
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHTY
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL RESOURCES INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 128 128
2017 82 82
2018 137 137
2019 222 222
2020 210 210

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 287 287
Break 182 182
Fracture 57 57
Mechanical Jam 44 44
Material Twisted/Bent 18 18
Migration or Expulsion of Device 16 16
Insufficient Information 15 15
Device Operates Differently Than Expected 15 15
Appropriate Term/Code Not Available 13 13
Patient-Device Incompatibility 11 11
Device-Device Incompatibility 11 11
Material Fragmentation 10 10
Entrapment of Device 9 9
Material Deformation 8 8
Physical Resistance/Sticking 8 8
Detachment of Device or Device Component 8 8
Separation Failure 8 8
Tip 8 8
Device Dislodged or Dislocated 7 7
Device Slipped 7 7
Failure to Osseointegrate 7 7
Wire 7 7
Pin 7 7
Difficult to Insert 6 6
Loose or Intermittent Connection 6 6
Difficult to Remove 6 6
Bent 6 6
Component Missing 5 5
Patient Device Interaction Problem 5 5
Suture Thread 5 5
Malposition of Device 5 5
Difficult to Advance 4 4
Improper or Incorrect Procedure or Method 4 4
Material Rupture 4 4
Detachment Of Device Component 4 4
Activation Failure 4 4
Migration 4 4
Expiration Date Error 4 4
Device Expiration Issue 4 4
Overheating of Device 3 3
Naturally Worn 3 3
Guidewire 3 3
Fitting Problem 3 3
Failure to Advance 3 3
Device Displays Incorrect Message 3 3
Material Integrity Problem 3 3
Unstable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Rod 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Positioning Problem 2 2
Unintended Movement 2 2
Switch, Push Button 2 2
Material Protrusion/Extrusion 2 2
Failure to Power Up 2 2
Screw 2 2
Failure to Align 2 2
Defective Device 2 2
Shelf Life Exceeded 2 2
Shipping Damage or Problem 2 2
Smoking 2 2
Use of Device Problem 2 2
Visual Prompts will not Clear 1 1
Microbial Contamination of Device 1 1
Material Separation 1 1
Sparking 1 1
Cut In Material 1 1
Socket 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Material Puncture/Hole 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Fire 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Needle 1 1
Missing Value Reason 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Cannula 1 1
Trocar 1 1
Device Fell 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Component Falling 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Device Damaged Prior to Use 1 1
Flaked 1 1
Connection Problem 1 1
Device Disinfection Or Sterilization Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 106 106
No Code Available 106 106
Unspecified Infection 101 101
No Known Impact Or Consequence To Patient 101 101
Pain 61 61
Injury 46 46
No Patient Involvement 38 38
Non-union Bone Fracture 34 34
Foreign Body In Patient 34 34
Failure of Implant 33 33
Device Embedded In Tissue or Plaque 32 32
Not Applicable 31 31
Post Operative Wound Infection 27 27
Tissue Damage 27 27
No Information 20 20
Swelling 17 17
Impaired Healing 15 15
Cellulitis 14 14
No Clinical Signs, Symptoms or Conditions 12 12
Bone Fracture(s) 10 10
Inflammation 9 9
Loss of Range of Motion 8 8
Discomfort 7 7
Necrosis 6 6
Joint Disorder 5 5
Thrombosis 5 5
Organ Dehiscence 5 5
Wound Dehiscence 4 4
Patient Problem/Medical Problem 4 4
Nerve Damage 4 4
Bacterial Infection 4 4
Implant Pain 3 3
Pulmonary Embolism 3 3
Arthritis 3 3
Rash 3 3
Fever 3 3
Insufficient Information 3 3
Hypersensitivity/Allergic reaction 3 3
Fracture, Arm 3 3
Hypoesthesia 2 2
Deformity/ Disfigurement 2 2
Osteolysis 2 2
Fluid Discharge 2 2
Irritation 2 2
Cyst(s) 2 2
Erythema 2 2
Reaction 2 2
Adhesion(s) 2 2
Edema 2 2
Complaint, Ill-Defined 2 2
Synovitis 2 2
Pleural Effusion 1 1
Burning Sensation 1 1
Embolus 1 1
Foreign Body Reaction 1 1
Weight Changes 1 1
Inadequate Osseointegration 1 1
Thromboembolism 1 1
Fall 1 1
Fatigue 1 1
Erosion 1 1
Abscess 1 1
Hematoma 1 1
Skin Irritation 1 1
Sweating 1 1
Joint Dislocation 1 1
Malaise 1 1
Rupture 1 1
Ulcer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Dec-22-2016
2 Biomet, Inc. II May-26-2016
3 Brasseler USA I Lp II Jan-29-2020
4 MicroAire Surgical Instruments, LLC II Mar-03-2017
5 Trilliant Surgical, LLC II Apr-01-2020
6 Zimmer Biomet, Inc. II Jun-01-2018
7 Zimmer Biomet, Inc. II Oct-14-2016
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