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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 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Break 344 344
Adverse Event Without Identified Device or Use Problem 252 256
Detachment of Device or Device Component 123 123
Fracture 78 78
Migration 32 35
Device Dislodged or Dislocated 31 31
Manufacturing, Packaging or Shipping Problem 29 29
Device-Device Incompatibility 29 29
Physical Resistance/Sticking 22 22
Difficult to Advance 21 21
Material Split, Cut or Torn 19 19
Material Separation 17 17
Appropriate Term/Code Not Available 17 17
Migration or Expulsion of Device 16 16
Crack 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Insufficient Information 13 13
Entrapment of Device 9 9
Material Frayed 9 9
Material Deformation 8 8
Patient Device Interaction Problem 8 8
No Apparent Adverse Event 6 6
Material Fragmentation 6 6
Failure to Advance 6 6
Difficult to Remove 5 5
Unintended Movement 5 5
Material Twisted/Bent 5 5
Mechanical Jam 4 4
Patient-Device Incompatibility 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
Device Damaged by Another Device 3 3
Packaging Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Therapeutic or Diagnostic Output Failure 2 2
Failure to Eject 2 2
Firing Problem 2 2
Failure to Align 2 2
Material Integrity Problem 2 2
Failure to Form Staple 2 2
Failure to Cut 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Component Missing 2 2
Fitting Problem 2 2
Flaked 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 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
Output above Specifications 1 1
Off-Label Use 1 1
Device Damaged Prior to Use 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Loss of Osseointegration 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Expulsion 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 449 449
No Consequences Or Impact To Patient 104 104
Pain 80 80
No Code Available 59 59
Non-union Bone Fracture 58 58
Insufficient Information 56 56
Injury 55 55
Tissue Damage 48 48
Failure of Implant 46 46
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
Perforation 15 15
Impaired Healing 14 14
No Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 11 15
Discomfort 11 11
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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