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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, INC.
  SUBSTANTIALLY EQUIVALENT 1
A.M. SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
PACIFIC INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 82 82
2018 138 138
2019 222 222
2020 210 210
2021 149 149
2022 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 353 353
Break 191 191
Fracture 70 70
Mechanical Jam 47 47
Material Twisted/Bent 20 20
Insufficient Information 17 17
Material Deformation 15 15
Device-Device Incompatibility 14 14
Entrapment of Device 14 14
Appropriate Term/Code Not Available 14 14
Detachment of Device or Device Component 12 12
Patient-Device Incompatibility 10 10
Device Operates Differently Than Expected 10 10
Separation Failure 10 10
Material Fragmentation 10 10
Migration or Expulsion of Device 10 10
Loose or Intermittent Connection 9 9
Physical Resistance/Sticking 9 9
Migration 8 8
Device Slipped 8 8
Difficult to Remove 7 7
Device Dislodged or Dislocated 7 7
Improper or Incorrect Procedure or Method 6 6
Use of Device Problem 6 6
Activation Failure 6 6
Patient Device Interaction Problem 5 5
Positioning Problem 5 5
Malposition of Device 5 5
Expiration Date Error 4 4
Unstable 4 4
Component Missing 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Advance 4 4
Failure to Power Up 4 4
Difficult to Insert 4 4
Device Expiration Issue 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Material Split, Cut or Torn 4 4
Bent 3 3
Detachment Of Device Component 3 3
Material Protrusion/Extrusion 3 3
Output Problem 3 3
Failure to Advance 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Tear, Rip or Hole in Device Packaging 2 2
Delivered as Unsterile Product 2 2
Material Rupture 2 2
Shipping Damage or Problem 2 2
Failure to Osseointegrate 2 2
Naturally Worn 2 2
Device Fell 1 1
Separation Problem 1 1
No Apparent Adverse Event 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Smoking 1 1
Unraveled Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Nonstandard Device 1 1
Corroded 1 1
Positioning Failure 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Partial Blockage 1 1
Flaked 1 1
Mechanical Problem 1 1
Image Display Error/Artifact 1 1
Cut In Material 1 1
Failure to Align 1 1
Fitting Problem 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Failure to Cut 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Difficult to Open or Close 1 1
Connection Problem 1 1
Device Disinfection Or Sterilization Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 102 102
No Consequences Or Impact To Patient 101 101
No Code Available 77 77
No Clinical Signs, Symptoms or Conditions 65 65
No Known Impact Or Consequence To Patient 63 63
Pain 56 56
Injury 45 45
Failure of Implant 43 43
Swelling/ Edema 42 42
Non-union Bone Fracture 37 37
No Patient Involvement 34 34
Foreign Body In Patient 34 34
Not Applicable 31 31
Insufficient Information 31 31
Implant Pain 30 30
Post Operative Wound Infection 27 27
Tissue Damage 27 27
Device Embedded In Tissue or Plaque 26 26
Discomfort 24 24
Impaired Healing 16 16
No Information 16 16
Swelling 14 14
Cellulitis 14 14
Bone Fracture(s) 12 12
Loss of Range of Motion 9 9
Inflammation 9 9
Unspecified Tissue Injury 9 9
Necrosis 7 7
Nerve Damage 5 5
Organ Dehiscence 5 5
Joint Disorder 5 5
Thrombosis 5 5
Physical Asymmetry 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Deformity/ Disfigurement 4 4
Patient Problem/Medical Problem 4 4
Fall 4 4
Wound Dehiscence 4 4
Pulmonary Embolism 3 3
Arthritis 3 3
Bacterial Infection 3 3
Erythema 3 3
Hypersensitivity/Allergic reaction 3 3
Malunion of Bone 3 3
Unspecified Musculoskeletal problem 3 3
Fracture, Arm 3 3
Hypoesthesia 2 2
Osteolysis 2 2
Skin Inflammation/ Irritation 2 2
Joint Laxity 2 2
Neuropathy 2 2
Irritation 2 2
Rash 2 2
Sepsis 2 2
Synovitis 2 2
Adhesion(s) 2 2
Erosion 2 2
Cyst(s) 2 2
Edema 2 2
Fluid Discharge 2 2
Embolus 1 1
Abscess 1 1
Hematoma 1 1
Fatigue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Perforation 1 1
Pleural Effusion 1 1
Skin Irritation 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Joint Contracture 1 1
Thromboembolism 1 1
Weight Changes 1 1
Needle Stick/Puncture 1 1
Sweating 1 1
Joint Dislocation 1 1
Rupture 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Hip Fracture 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 MicroAire Surgical Instruments, LLC II Mar-03-2017
4 Paragon 28, Inc. II Jul-27-2022
5 Stryker GmbH II Apr-27-2022
6 Trilliant Surgical, LLC II Apr-01-2020
7 Zimmer Biomet, Inc. II Jun-01-2018
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