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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
2017 12 12
2018 11 11
2019 17 17
2020 9 9
2021 9 9
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 33
Adverse Event Without Identified Device or Use Problem 11 11
Failure to Cut 4 4
Contamination /Decontamination Problem 3 3
Material Deformation 3 3
Entrapment of Device 3 3
Fracture 3 3
Material Fragmentation 2 2
Dull, Blunt 2 2
Device Contamination with Chemical or Other Material 2 2
Bent 1 1
Device-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Failure to Obtain Sample 1 1
Detachment Of Device Component 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Code Available 13 13
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 6 6
No Patient Involvement 3 3
Device Embedded In Tissue or Plaque 3 3
Injury 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Fatigue 1 1
Nerve Damage 1 1
Paresis 1 1
Weakness 1 1
No Information 1 1
Unspecified Tissue Injury 1 1
Decreased Sensitivity 1 1
Patient Problem/Medical Problem 1 1

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