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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device staple, fixation, bone
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RMR ORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 242 242
2020 234 234
2021 210 210
2022 202 209
2023 175 175
2024 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Break 338 338
Adverse Event Without Identified Device or Use Problem 247 251
Detachment of Device or Device Component 123 123
Fracture 75 75
Device Dislodged or Dislocated 31 31
Migration 30 33
Device-Device Incompatibility 29 29
Manufacturing, Packaging or Shipping Problem 29 29
Difficult to Advance 21 21
Physical Resistance/Sticking 20 20
Material Split, Cut or Torn 19 19
Appropriate Term/Code Not Available 17 17
Material Separation 17 17
Migration or Expulsion of Device 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Crack 13 13
Insufficient Information 13 13
Entrapment of Device 9 9
Material Frayed 9 9
Patient Device Interaction Problem 8 8
Material Deformation 8 8
No Apparent Adverse Event 6 6
Material Fragmentation 6 6
Difficult to Remove 5 5
Unintended Movement 5 5
Material Twisted/Bent 5 5
Failure to Advance 5 5
Patient-Device Incompatibility 4 4
Mechanical Jam 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Activation Problem 4 4
Inaccurate Information 4 4
Corroded 3 3
Delivered as Unsterile Product 3 3
Defective Component 3 3
Packaging Problem 3 3
Device Damaged by Another Device 3 3
Failure to Align 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Failure to Form Staple 2 2
Failure to Cut 2 2
Material Integrity Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Flaked 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Failure to Eject 2 2
Firing Problem 2 2
Material Disintegration 1 1
Unintended Ejection 1 1
Degraded 1 1
Melted 1 1
Nonstandard Device 1 1
Difficult to Insert 1 1
Device Slipped 1 1
Stretched 1 1
Unstable 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Output above Specifications 1 1
Off-Label Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1
Output Problem 1 1
Defective Device 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 437 437
No Consequences Or Impact To Patient 104 104
Pain 80 80
No Code Available 59 59
Non-union Bone Fracture 58 58
Injury 55 55
Insufficient Information 49 49
Tissue Damage 48 48
Failure of Implant 45 45
Not Applicable 45 45
No Known Impact Or Consequence To Patient 41 41
Foreign Body In Patient 34 34
Unspecified Infection 28 28
Unspecified Tissue Injury 23 23
Loss of Range of Motion 21 24
Bone Fracture(s) 20 20
No Patient Involvement 19 19
Post Operative Wound Infection 19 19
Impaired Healing 14 14
Perforation 14 14
No Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 11 15
Discomfort 10 10
Wound Dehiscence 8 8
Hypersensitivity/Allergic reaction 6 6
Foreign Body Reaction 5 5
Device Embedded In Tissue or Plaque 5 5
Malunion of Bone 4 4
Joint Dislocation 4 4
Hematoma 4 4
Cyst(s) 4 4
Fall 4 4
Abscess 4 4
Inflammation 4 4
Rupture 4 4
Arthritis 3 3
Cellulitis 3 3
Osteolysis 3 3
Synovitis 3 3
Skin Infection 3 3
Swelling/ Edema 3 3
Skin Inflammation/ Irritation 2 2
Numbness 2 2
Unspecified Musculoskeletal problem 2 2
Physical Asymmetry 2 2
Stroke/CVA 2 2
Bacterial Infection 2 2
Erosion 2 2
Fever 2 2
Ulcer 2 2
Nerve Damage 2 2
Swelling 2 2
Muscular Rigidity 2 2
Necrosis 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Lupus 1 1
Seroma 1 1
Skin Discoloration 1 1
Weakness 1 1
Erythema 1 1
Hyperplasia 1 1
Ossification 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Joint Contracture 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Joint Disorder 1 1
Reaction 1 1
Organ Dehiscence 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-18-2022
2 Merete Medical GmbH II Feb-17-2022
3 Stryker GmbH II Nov-16-2020
4 Synthes (USA) Products LLC II Oct-18-2022
5 Synthes (USA) Products LLC II Oct-06-2022
6 Wright Medical Technology, Inc. II Mar-31-2022
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