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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, surgical instrument, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 63 64
2022 12 14
2023 43 43
2024 58 58
2025 33 33
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Lubrication 92 92
Adverse Event Without Identified Device or Use Problem 24 24
Break 16 16
Material Integrity Problem 9 9
Output Problem 8 8
Contamination 6 6
Device Damaged by Another Device 6 6
Appropriate Term/Code Not Available 5 5
Delivered as Unsterile Product 5 5
Improper or Incorrect Procedure or Method 4 4
No Apparent Adverse Event 4 4
Expiration Date Error 4 4
Material Fragmentation 4 4
Fluid/Blood Leak 3 4
Loss of or Failure to Bond 3 3
Inaccurate Information 3 3
Insufficient Information 3 3
Defective Device 3 3
Microbial Contamination of Device 3 3
Contamination /Decontamination Problem 3 3
Leak/Splash 2 2
Fracture 2 2
Device Contamination with Chemical or Other Material 2 2
Patient-Device Incompatibility 2 2
Product Quality Problem 2 4
Component Missing 2 2
Protective Measures Problem 1 1
Detachment of Device or Device Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Handling Problem 1 1
Packaging Problem 1 1
Material Deformation 1 1
Failure to Cut 1 1
Obstruction of Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Filling Problem 1 1
Material Disintegration 1 1
Device Markings/Labelling Problem 1 1
Peeled/Delaminated 1 1
Physical Resistance/Sticking 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
Failure of Implant 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Fluid Discharge 15 18
Unspecified Infection 14 14
Insufficient Information 13 13
Foreign Body In Patient 9 9
Wound Dehiscence 5 5
Inflammation 5 5
Pain 5 5
Purulent Discharge 4 4
Fever 4 5
Erythema 3 5
Impaired Healing 2 2
Necrosis 2 2
Post Operative Wound Infection 2 2
Rash 2 2
Bacterial Infection 2 2
Breast Discomfort/Pain 2 4
Decreased Sensitivity 1 1
Unspecified Gastrointestinal Problem 1 1
Muscle Weakness 1 1
Local Reaction 1 1
Blister 1 1
Itching Sensation 1 1
Chills 1 1
Seroma 1 1
Nerve Damage 1 1
Eye Infections 1 1
Swelling/ Edema 1 1
Tissue Breakdown 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allergan Sales, LLC II Apr-29-2024
2 Beaver Visitec International, Inc. II Aug-28-2024
3 Beaver Visitec International, Inc. II Mar-01-2023
4 Biomet, Inc. II Nov-15-2024
5 Bioseal Corporation II May-20-2021
6 DeRoyal Industries Inc II Nov-05-2024
7 DeRoyal Industries Inc II Jul-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
9 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
16 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
21 MICROspecialties, Inc. II Jul-11-2024
22 Medical Action Industries, Inc. 306 II Jun-24-2021
23 Medline Industries, LP II Feb-17-2026
24 Medline Industries, LP II Nov-14-2025
25 Stryker Corporation II Nov-09-2023
26 Synergetics Inc I Jul-11-2024
27 Vortex Surgical Inc. II Feb-04-2026
28 Windstone Medical Packaging, Inc. I Feb-16-2024
29 Windstone Medical Packaging, Inc. II May-23-2023
30 Windstone Medical Packaging, Inc. II Jan-04-2023
31 Windstone Medical Packaging, Inc. II May-17-2022
32 Windstone Medical Packaging, Inc. II Jun-11-2021
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