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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
Product CodeHTY
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
A.M. SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ELECTRO-SPEC, INC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 5
PACIFIC INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 138 138
2019 222 222
2020 210 210
2021 148 148
2022 95 95
2023 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 360 360
Break 209 209
Fracture 71 71
Mechanical Jam 43 43
Insufficient Information 19 19
Material Twisted/Bent 19 19
Migration 17 17
Detachment of Device or Device Component 16 16
Entrapment of Device 16 16
Device-Device Incompatibility 15 15
Appropriate Term/Code Not Available 12 12
Physical Resistance/Sticking 11 11
Material Deformation 11 11
Separation Failure 10 10
Patient-Device Incompatibility 10 10
Loose or Intermittent Connection 9 9
Material Fragmentation 8 8
Migration or Expulsion of Device 7 7
Device Operates Differently Than Expected 7 7
Patient Device Interaction Problem 7 7
Device Dislodged or Dislocated 6 6
Improper or Incorrect Procedure or Method 6 6
Device Slipped 6 6
Use of Device Problem 5 5
Failure to Power Up 5 5
Malposition of Device 5 5
Difficult to Advance 5 5
Positioning Problem 5 5
Activation Failure 5 5
Material Split, Cut or Torn 5 5
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Unstable 4 4
Defective Device 4 4
Failure to Advance 4 4
Expiration Date Error 4 4
Difficult to Remove 4 4
Product Quality Problem 3 3
Device Displays Incorrect Message 3 3
Unintended Movement 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Naturally Worn 2 2
Material Protrusion/Extrusion 2 2
Failure to Cut 2 2
Component Missing 2 2
Inadequacy of Device Shape and/or Size 2 2
Off-Label Use 2 2
Failure to Osseointegrate 2 2
Material Rupture 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Positioning Failure 2 2
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Corroded 1 1
Bent 1 1
Partial Blockage 1 1
Material Frayed 1 1
Image Display Error/Artifact 1 1
Mechanical Problem 1 1
Device Expiration Issue 1 1
Flaked 1 1
Nonstandard Device 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Smoking 1 1
Unraveled Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Sparking 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Scratched Material 1 1
Device Fell 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 109
Unspecified Infection 100 100
No Consequences Or Impact To Patient 97 97
No Code Available 62 62
Pain 56 56
Failure of Implant 52 52
Non-union Bone Fracture 46 46
Injury 45 45
Insufficient Information 45 45
Swelling/ Edema 42 42
No Known Impact Or Consequence To Patient 42 42
Foreign Body In Patient 37 37
Post Operative Wound Infection 33 33
Not Applicable 31 31
Implant Pain 31 31
Discomfort 26 26
Tissue Damage 26 26
No Patient Involvement 25 25
Device Embedded In Tissue or Plaque 21 21
Bone Fracture(s) 19 19
Cellulitis 14 14
Impaired Healing 14 14
Swelling 14 14
Inflammation 10 10
Loss of Range of Motion 10 10
Unspecified Tissue Injury 10 10
No Information 9 9
Physical Asymmetry 8 8
Necrosis 7 7
Nerve Damage 7 7
Bacterial Infection 6 6
Deformity/ Disfigurement 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Skin Inflammation/ Irritation 6 6
Unspecified Musculoskeletal problem 5 5
Malunion of Bone 5 5
Joint Disorder 5 5
Thrombosis 5 5
Organ Dehiscence 5 5
Patient Problem/Medical Problem 4 4
Fall 4 4
Hypersensitivity/Allergic reaction 4 4
Erythema 3 3
Neuropathy 3 3
Wound Dehiscence 3 3
Pulmonary Embolism 3 3
Arthritis 3 3
Fracture, Arm 3 3
Hypoesthesia 2 2
Osteolysis 2 2
Synovitis 2 2
Adhesion(s) 2 2
Erosion 2 2
Cyst(s) 2 2
Edema 2 2
Perforation 2 2
Rash 2 2
Sepsis 2 2
Hematoma 2 2
Limb Fracture 2 2
Joint Laxity 2 2
Fluid Discharge 2 2
Drug Resistant Bacterial Infection 1 1
Joint Contracture 1 1
Muscle/Tendon Damage 1 1
Irritation 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Skin Irritation 1 1
Pleural Effusion 1 1
Embolus 1 1
Granuloma 1 1
Fatigue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Purulent Discharge 1 1
Abscess 1 1
Urinary Retention 1 1
Rupture 1 1
Ulcer 1 1
Joint Dislocation 1 1
Hip Fracture 1 1
Paresthesia 1 1
Pseudoaneurysm 1 1
Weight Changes 1 1
Thromboembolism 1 1
Inadequate Pain Relief 1 1
Sweating 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brasseler USA I Lp II Jan-29-2020
2 Brasseler USA, Medical L.L.C. II Mar-01-2022
3 Paragon 28, Inc. II Jul-27-2022
4 Stryker GmbH II Apr-27-2022
5 Trilliant Surgical, LLC II Apr-01-2020
6 Zimmer Biomet, Inc. II Jun-01-2018
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