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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 2
ARCURO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CETERIX ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 3
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
THREADSTONE L.L.C.
  SUBSTANTIALLY EQUIVALENT 3
THREADSTONE LLC
  SUBSTANTIALLY EQUIVALENT 1
WINTER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1104 1104
2018 1453 1457
2019 1251 1251
2020 1225 1225
2021 1643 1767
2022 1419 1424
2023 2038 2038
2024 2598 2598
2025 2408 2408

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 2876 2876
Break 2369 2374
Firing Problem 1832 1832
Adverse Event Without Identified Device or Use Problem 1332 1332
Device Dislodged or Dislocated 1206 1206
Material Separation 929 929
Premature Activation 843 843
Activation, Positioning or Separation Problem 578 578
Detachment of Device or Device Component 497 497
Positioning Failure 401 401
Physical Resistance/Sticking 401 401
Failure to Cycle 308 308
Failure to Advance 198 198
Device Operates Differently Than Expected 169 172
Material Twisted/Bent 151 151
Detachment Of Device Component 146 146
Material Split, Cut or Torn 141 141
Insufficient Information 141 141
Appropriate Term/Code Not Available 119 119
Unintended Ejection 113 113
Component Missing 94 94
Material Frayed 76 76
Misfire 72 72
Material Deformation 63 65
Loose or Intermittent Connection 62 62
Activation Problem 59 59
Patient Device Interaction Problem 56 56
Mechanical Problem 56 56
Component Falling 56 56
Device Fell 52 52
Mechanical Jam 51 52
Use of Device Problem 48 49
Unraveled Material 47 47
Patient-Device Incompatibility 45 45
Migration 44 44
Device Slipped 44 44
Product Quality Problem 42 42
Device Markings/Labelling Problem 39 40
Unstable 39 39
Material Integrity Problem 36 36
Component Misassembled 33 33
Crack 32 32
Delivered as Unsterile Product 32 32
Device Contaminated During Manufacture or Shipping 32 32
Manufacturing, Packaging or Shipping Problem 32 32
Material Fragmentation 32 32
Migration or Expulsion of Device 31 31
Packaging Problem 31 31
Defective Device 31 31
Fracture 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8345 8345
No Known Impact Or Consequence To Patient 2820 2823
No Consequences Or Impact To Patient 855 855
Insufficient Information 574 577
Device Embedded In Tissue or Plaque 525 526
No Information 344 344
Unspecified Infection 323 323
Foreign Body In Patient 294 295
Not Applicable 267 267
Pain 254 256
No Code Available 202 202
Hemorrhage/Bleeding 116 116
Injury 115 115
Wound Dehiscence 102 102
Unspecified Tissue Injury 100 222
Inflammation 84 84
Post Operative Wound Infection 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 79
Hernia 75 75
Granuloma 69 69
Failure of Implant 64 64
Hematoma 63 63
Erosion 51 51
Abscess 50 52
Blood Loss 46 46
Seroma 43 43
Obstruction/Occlusion 41 41
Fistula 40 40
Swelling/ Edema 39 39
Impaired Healing 37 37
Incontinence 35 35
Fever 34 34
Foreign Body Reaction 33 33
No Patient Involvement 33 33
Fluid Discharge 30 30
Discomfort 29 29
Tissue Damage 29 29
Urinary Tract Infection 29 29
Adhesion(s) 29 29
Loss of Range of Motion 28 28
Sepsis 28 28
Erythema 27 29
Eye Injury 27 27
Necrosis 25 25
Pocket Erosion 24 24
Post Traumatic Wound Infection 23 23
Nerve Damage 22 22
Fibrosis 22 22
Swelling 22 22
Laceration(s) 21 21

Recalls
Manufacturer Recall Class Date Posted
1 ArthroCare Corporation II Sep-22-2020
2 Covidien, LP II Feb-25-2023
3 Musculoskeletal Transplant Foundation, Inc. II Sep-20-2019
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