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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device awl
Product CodeHWJ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2018 11 11
2019 17 17
2020 9 9
2021 9 9
2022 10 10
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 30 30
Adverse Event Without Identified Device or Use Problem 11 11
Failure to Cut 5 5
Material Deformation 4 4
Contamination /Decontamination Problem 3 3
Entrapment of Device 3 3
Fracture 2 2
Dull, Blunt 2 2
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Material Fragmentation 1 1
Device Damaged Prior to Use 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Code Available 13 13
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
Insufficient Information 3 3
Injury 2 2
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Fatigue 1 1
Nerve Damage 1 1
Paresis 1 1
Weakness 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Tissue Injury 1 1
Decreased Sensitivity 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Apr-24-2020
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