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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device punch, surgical
Product CodeLRY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 77 77
2020 86 86
2021 68 68
2022 57 57
2023 46 46
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 98 98
Device-Device Incompatibility 76 76
Material Twisted/Bent 53 53
Material Deformation 34 34
Naturally Worn 22 22
Dull, Blunt 17 17
Failure to Cut 15 15
Physical Resistance/Sticking 15 15
Material Integrity Problem 13 13
Contamination /Decontamination Problem 9 9
Material Fragmentation 9 9
Mechanical Problem 8 8
Mechanical Jam 8 8
Connection Problem 7 7
Difficult to Remove 6 6
Entrapment of Device 5 5
Compatibility Problem 4 4
Packaging Problem 4 4
Detachment of Device or Device Component 3 3
Fracture 3 3
Loose or Intermittent Connection 3 3
Defective Device 3 3
Sharp Edges 3 3
Illegible Information 3 3
Insufficient Information 3 3
Material Too Soft/Flexible 3 3
Use of Device Problem 2 2
Off-Label Use 2 2
Device Contaminated During Manufacture or Shipping 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Device Slipped 1 1
Deformation Due to Compressive Stress 1 1
Nonstandard Device 1 1
Crack 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 176 176
No Consequences Or Impact To Patient 101 101
Not Applicable 25 25
No Code Available 24 24
Insufficient Information 15 15
Perforation of Vessels 12 12
No Known Impact Or Consequence To Patient 9 9
No Information 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Asystole 1 1
Great Vessel Perforation 1 1
Swelling 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1
Excessive Tear Production 1 1
Joint Disorder 1 1
Needle Stick/Puncture 1 1
Skin Tears 1 1
Intraoperative Pain 1 1
Foreign Body In Patient 1 1

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