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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable, steel, monofilament and multifilament, sterile
Product CodeGAQ
Regulation Number 878.4495
Device Class 2


Premarket Reviews
ManufacturerDecision
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOOSIN MEDICAL SUPPLIES INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 76 76
2020 52 52
2021 39 39
2022 70 70
2023 100 100
2024 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
Break 177 177
Material Separation 177 177
Detachment of Device or Device Component 65 65
Adverse Event Without Identified Device or Use Problem 24 24
Material Twisted/Bent 12 12
Defective Component 6 6
Dull, Blunt 6 6
Delivered as Unsterile Product 5 5
Product Quality Problem 4 4
Unraveled Material 4 4
Use of Device Problem 2 2
Material Frayed 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unclear Information 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Migration 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Misfire 1 1
Component Missing 1 1
Loose or Intermittent Connection 1 1
Corroded 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 268
No Consequences Or Impact To Patient 81 81
Hemorrhage/Bleeding 23 23
Insufficient Information 22 22
Not Applicable 17 17
Wound Dehiscence 12 12
Foreign Body In Patient 9 9
Tissue Breakdown 8 8
No Code Available 8 8
No Known Impact Or Consequence To Patient 8 8
Unspecified Infection 7 7
Pain 7 7
Bone Fracture(s) 6 6
Tissue Damage 4 4
Hypersensitivity/Allergic reaction 3 3
Inflammation 3 3
Local Reaction 3 3
Toxicity 3 3
Foreign Body Reaction 3 3
Hemostasis 3 3
Unintended Radiation Exposure 2 2
Granuloma 2 2
Unspecified Tissue Injury 2 2
Blood Loss 2 2
Rupture 2 2
Itching Sensation 2 2
No Information 2 2
Erythema 1 1
No Patient Involvement 1 1
Rash 1 1
Dyspnea 1 1
Fever 1 1
Cardiac Arrest 1 1
Renal Impairment 1 1
Pneumonia 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Ischemia 1 1
Radiation Exposure, Unintended 1 1
Respiratory Failure 1 1
Skin Irritation 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jun-19-2019
2 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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