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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
A.M. SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHALANX INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL RESOURCES INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTORR INC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 128 128
2017 82 82
2018 137 137
2019 222 222
2020 210 210
2021 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 349 349
Break 202 202
Fracture 66 66
Mechanical Jam 45 45
Material Twisted/Bent 18 18
Appropriate Term/Code Not Available 16 16
Migration or Expulsion of Device 16 16
Insufficient Information 15 15
Device Operates Differently Than Expected 15 15
Entrapment of Device 13 13
Device-Device Incompatibility 12 12
Patient-Device Incompatibility 11 11
Material Fragmentation 10 10
Material Deformation 10 10
Loose or Intermittent Connection 9 9
Detachment of Device or Device Component 9 9
Device Slipped 9 9
Separation Failure 8 8
Migration 8 8
Physical Resistance/Sticking 8 8
Improper or Incorrect Procedure or Method 7 7
Failure to Osseointegrate 7 7
Device Dislodged or Dislocated 7 7
Difficult to Remove 6 6
Bent 6 6
Difficult to Insert 6 6
Malposition of Device 5 5
Activation Failure 5 5
Component Missing 5 5
Patient Device Interaction Problem 5 5
Expiration Date Error 4 4
Use of Device Problem 4 4
Device Expiration Issue 4 4
Difficult to Advance 4 4
Positioning Problem 4 4
Unstable 4 4
Material Rupture 4 4
Detachment Of Device Component 4 4
Fitting Problem 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Advance 3 3
Device Displays Incorrect Message 3 3
Overheating of Device 3 3
Failure to Power Up 3 3
Failure to Align 3 3
Material Protrusion/Extrusion 3 3
Naturally Worn 3 3
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Smoking 2 2
Shelf Life Exceeded 2 2
Shipping Damage or Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Unintended Movement 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Flaked 1 1
Image Display Error/Artifact 1 1
Component Falling 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Device Damaged Prior to Use 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Device Fell 1 1
Connection Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Visual Prompts will not Clear 1 1
Microbial Contamination of Device 1 1
Sparking 1 1
Cut In Material 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Fire 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
Torn Material 1 1
No Apparent Adverse Event 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Material Split, Cut or Torn 1 1
Missing Value Reason 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Device Operational Issue 1 1
Difficult to Open or Close 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 104 104
No Known Impact Or Consequence To Patient 101 101
Pain 69 69
Injury 46 46
Failure of Implant 43 43
Non-union Bone Fracture 41 41
No Patient Involvement 38 38
Foreign Body In Patient 38 38
Device Embedded In Tissue or Plaque 33 33
No Clinical Signs, Symptoms or Conditions 33 33
Not Applicable 31 31
Swelling/ Edema 30 30
Post Operative Wound Infection 28 28
Tissue Damage 27 27
Implant Pain 26 26
No Information 20 20
Impaired Healing 17 17
Swelling 17 17
Insufficient Information 15 15
Bone Fracture(s) 15 15
Cellulitis 14 14
Discomfort 13 13
Inflammation 10 10
Loss of Range of Motion 10 10
Necrosis 6 6
Nerve Damage 5 5
Joint Disorder 5 5
Unspecified Tissue Injury 5 5
Thrombosis 5 5
Physical Asymmetry 5 5
Organ Dehiscence 5 5
Wound Dehiscence 4 4
Fall 4 4
Hypersensitivity/Allergic reaction 4 4
Patient Problem/Medical Problem 4 4
Bacterial Infection 4 4
Malunion of Bone 3 3
Erythema 3 3
Pulmonary Embolism 3 3
Arthritis 3 3
Rash 3 3
Fever 3 3
Deformity/ Disfigurement 3 3
Fracture, Arm 3 3
Hypoesthesia 2 2
Osteolysis 2 2
Fluid Discharge 2 2
Irritation 2 2
Cyst(s) 2 2
Skin Inflammation/ Irritation 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
Needle Stick/Puncture 1 1
Weight Changes 1 1
Inadequate Osseointegration 1 1
Thromboembolism 1 1
Joint Laxity 1 1
Joint Contracture 1 1
Fatigue 1 1
Erosion 1 1
Abscess 1 1
Neuropathy 1 1
Perforation 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
Hip Fracture 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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