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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable, synthetic, polyethylene
Regulation Description Nonabsorbable poly(ethylene terephthalate) surgical suture.
Product CodeGAT
Regulation Number 878.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLOSOURCE
  SUBSTANTIALLY EQUIVALENT 1
ARCURO MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
THREADSTONE, LLC
  SUBSTANTIALLY EQUIVALENT 5
WINTER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1643 1767
2022 1419 1424
2023 2038 2042
2024 2597 2598
2025 3001 3002
2026 2405 2405

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 3250 3250
Break 1916 1916
Firing Problem 1891 1892
Device Dislodged or Dislocated 1692 1692
Adverse Event Without Identified Device or Use Problem 1076 1078
Premature Activation 733 733
Material Separation 673 674
Physical Resistance/Sticking 640 640
Failure to Cycle 540 540
Detachment of Device or Device Component 430 431
Material Twisted/Bent 272 272
Failure to Advance 173 173
Patient Device Interaction Problem 135 135
Material Split, Cut or Torn 119 119
Material Deformation 87 87
Component Missing 82 82
Insufficient Device Problem Information 63 63
Fracture 60 60
Material Frayed 56 56
Positioning Failure 54 54
Migration 48 49
Unstable 44 44
Device Contaminated During Manufacture or Shipping 42 42
Delivered as Unsterile Product 40 40
Product Quality Problem 39 39
Use of Device Problem 38 38
Component Misassembled 32 32
Unraveled Material 32 32
Material Fragmentation 28 28
Mechanical Jam 28 28
Crack 27 27
Defective Device 25 25
Unintended Movement 24 24
Nonstandard Device 23 23
Biocompatibility 22 22
Manufacturing, Packaging or Shipping Problem 19 19
Material Integrity Problem 18 18
Difficult to Advance 18 18
Device Slipped 18 18
Mechanical Problem 17 17
Packaging Problem 17 17
Device Damaged by Another Device 15 15
Device Markings/Labelling Problem 14 14
Human-Device Interface Problem 13 13
Device-Device Incompatibility 12 12
Device Damaged Prior to Use 11 11
Appropriate Device Problem Term/Code Not Available 9 9
No Apparent Adverse Event 9 9
Missing Information 8 8
Dull, Blunt 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10733 10736
Insufficient Information 694 699
Device Embedded In Tissue or Plaque 626 626
Unspecified Infection 259 259
Foreign Body In Patient 251 253
Pain 195 197
Hemorrhage/Blood Loss/Bleeding 126 126
Unspecified Tissue Injury 110 232
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 79 80
Wound Dehiscence 78 78
Failure of Implant 63 63
Granuloma 51 51
Post Operative Wound Infection 48 49
Hernia 45 45
Inflammation 45 45
Hematoma 45 45
Swelling/ Edema 44 44
Cartilage damage 34 34
Impaired Healing 33 33
Obstruction/Occlusion 31 31
Fistula 29 29
Fluid Discharge 29 29
Loss of Range of Motion 28 28
Pocket Erosion 27 27
Fever 26 26
Discomfort 24 24
Incontinence 24 24
Adhesion(s) 24 24
Erosion 23 23
Muscle/Tendon Damage 23 23
Wound Infection 22 22
Laceration(s) 22 22
Rupture 22 22
Eye Injury 22 22
Joint Dislocation 21 21
Sepsis 21 21
Abscess 21 23
Scar Tissue 20 20
Seroma 19 19
Perforation 19 19
Damage to Ligament(s) 18 18
Nerve Damage 18 18
Necrosis 18 18
Prolapse 18 18
Thrombosis/Thrombus 17 17
Abdominal Pain 17 19
Failure to Anastomose 17 17
Joint Laxity 16 16
Bacterial Infection 16 18
Urinary Tract Infection 16 16

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Feb-25-2023
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