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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, manual, surgical, general use
Regulation Description Manual surgical instrument for general use.
Product CodeMDM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 244 244
2021 227 227
2022 182 182
2023 210 210
2024 507 507
2025 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 873 873
Physical Resistance/Sticking 52 52
Adverse Event Without Identified Device or Use Problem 50 50
Entrapment of Device 49 49
Difficult to Remove 48 48
Material Twisted/Bent 44 44
Fracture 38 38
Detachment of Device or Device Component 38 38
Material Fragmentation 32 32
Dull, Blunt 30 30
Corroded 19 19
Defective Device 19 19
Mechanical Jam 18 18
Appropriate Term/Code Not Available 17 17
Material Separation 16 16
Material Split, Cut or Torn 12 12
Mechanical Problem 11 11
Component Missing 11 11
Flaked 11 11
Fitting Problem 10 10
Material Deformation 10 10
Connection Problem 9 9
Device Damaged by Another Device 8 8
Failure to Disinfect 8 8
Activation, Positioning or Separation Problem 7 7
Naturally Worn 7 7
Failure to Cut 6 6
Crack 6 6
Use of Device Problem 6 6
Difficult to Open or Close 6 6
Patient Device Interaction Problem 6 6
Failure to Advance 6 6
Device Difficult to Maintain 5 5
Unintended Movement 5 5
Insufficient Information 5 5
Contamination /Decontamination Problem 5 5
Device Dislodged or Dislocated 4 4
Output Problem 4 4
Device-Device Incompatibility 4 4
Device Slipped 4 4
Inadequacy of Device Shape and/or Size 3 3
Difficult to Insert 3 3
Misfire 3 3
Incorrect Measurement 3 3
Device Damaged Prior to Use 3 3
Delivered as Unsterile Product 3 3
Separation Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Product Quality Problem 2 2
Melted 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 693 693
Insufficient Information 266 266
Foreign Body In Patient 199 199
Device Embedded In Tissue or Plaque 83 83
No Known Impact Or Consequence To Patient 66 66
No Consequences Or Impact To Patient 41 41
No Patient Involvement 31 31
Failure of Implant 19 19
Injury 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Unspecified Infection 9 9
Pain 9 9
Bone Fracture(s) 9 9
No Information 7 7
Unspecified Tissue Injury 6 6
Perforation 6 6
No Code Available 5 5
Low Blood Pressure/ Hypotension 4 4
Swelling/ Edema 4 4
Pericardial Effusion 4 4
Cardiac Tamponade 3 3
Post Operative Wound Infection 3 3
Tissue Damage 3 3
Purulent Discharge 2 2
Inflammation 2 2
Discomfort 2 2
Metal Related Pathology 2 2
Not Applicable 2 2
Laceration(s) 2 2
Joint Laxity 2 2
Heart Block 2 2
Internal Organ Perforation 2 2
Synovitis 1 1
Edema 1 1
Obstruction/Occlusion 1 1
Hematoma 1 1
Sepsis 1 1
Exposure to Body Fluids 1 1
Muscular Rigidity 1 1
Loss of Range of Motion 1 1
Cardiogenic Shock 1 1
Joint Dislocation 1 1
Increased Appetite 1 1
Subluxation 1 1
Arthralgia 1 1
Hip Fracture 1 1
Perforation of Vessels 1 1
Hypoxia 1 1
Ulcer 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Mar-27-2024
2 Arthrex, Inc. II Dec-08-2022
3 ENDO Pharmaceuticals Solutions, Inc. II Dec-30-2022
4 FlexDex Inc. II Jan-27-2022
5 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
8 Sklar Instruments II Jan-16-2025
9 Technicality Inc. II Apr-02-2024
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