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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 1
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 1

MDR Year MDR Reports MDR Events
2021 1643 1767
2022 1419 1424
2023 2038 2042
2024 2597 2598
2025 3001 3002
2026 1435 1435

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 2986 2986
Break 1892 1893
Firing Problem 1746 1747
Device Dislodged or Dislocated 1493 1493
Adverse Event Without Identified Device or Use Problem 1078 1080
Premature Activation 692 692
Material Separation 657 658
Physical Resistance/Sticking 604 604
Failure to Cycle 458 458
Detachment of Device or Device Component 406 407
Material Twisted/Bent 236 236
Failure to Advance 170 170
Patient Device Interaction Problem 126 126
Material Split, Cut or Torn 115 115
Material Deformation 81 83
Component Missing 79 79
Insufficient Information 65 65
Material Frayed 56 56
Fracture 55 55
Positioning Failure 48 48
Unstable 44 44
Device Contaminated During Manufacture or Shipping 41 41
Use of Device Problem 40 41
Migration 39 40
Product Quality Problem 39 39
Delivered as Unsterile Product 39 39
Unraveled Material 33 33
Component Misassembled 32 32
Mechanical Jam 31 32
Crack 28 28
Defective Device 27 27
Material Fragmentation 27 27
Unintended Movement 24 24
Nonstandard Device 23 23
Biocompatibility 22 22
Manufacturing, Packaging or Shipping Problem 19 19
Mechanical Problem 18 18
Device Slipped 18 18
Device Markings/Labelling Problem 17 18
Material Integrity Problem 17 17
Difficult to Advance 16 16
Packaging Problem 16 16
Activation, Positioning or Separation Problem 16 16
Device Damaged by Another Device 15 15
Human-Device Interface Problem 13 13
Activation Failure 13 13
Output Problem 12 13
Device Damaged Prior to Use 11 11
Appropriate Term/Code Not Available 9 9
Loose or Intermittent Connection 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9868 9871
Insufficient Information 675 680
Device Embedded In Tissue or Plaque 582 582
Unspecified Infection 245 245
Foreign Body In Patient 232 234
Pain 185 187
Hemorrhage/Bleeding 118 118
Unspecified Tissue Injury 108 230
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 76
Wound Dehiscence 72 72
Failure of Implant 61 61
Granuloma 51 51
Post Operative Wound Infection 48 49
Hernia 43 43
Hematoma 43 43
Inflammation 40 40
Swelling/ Edema 40 40
Impaired Healing 32 32
Obstruction/Occlusion 31 31
Fistula 29 29
Fluid Discharge 28 28
Loss of Range of Motion 28 28
Fever 25 25
Pocket Erosion 24 24
Incontinence 23 23
Adhesion(s) 23 23
Rupture 22 22
Eye Injury 22 22
Post Traumatic Wound Infection 22 22
Erosion 22 22
Discomfort 22 22
Abscess 21 23
Muscle/Tendon Damage 21 21
Sepsis 20 20
Laceration(s) 20 20
Joint Dislocation 20 20
Scar Tissue 20 20
Nerve Damage 18 18
Necrosis 18 18
Seroma 18 18
Damage to Ligament(s) 18 18
Perforation 17 17
Thrombosis/Thrombus 16 16
Failure to Anastomose 16 16
Abdominal Pain 16 18
Muscular Rigidity 15 15
Dysphagia/ Odynophagia 15 15
Bacterial Infection 15 17
Urinary Tract Infection 15 15
Prolapse 15 15

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