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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device impactor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWA
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 1477 1477
2021 2006 2006
2022 2086 2086
2023 2240 2240
2024 2009 2009
2025 724 724

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7556 7556
Crack 937 937
Naturally Worn 902 902
Device-Device Incompatibility 725 725
Fracture 553 553
Material Twisted/Bent 279 279
Material Deformation 273 273
Contamination /Decontamination Problem 202 202
Scratched Material 151 151
No Apparent Adverse Event 132 132
Material Integrity Problem 130 130
Mechanical Jam 76 76
Unintended Movement 70 70
Detachment of Device or Device Component 60 60
Adverse Event Without Identified Device or Use Problem 58 58
Illegible Information 39 39
Entrapment of Device 32 32
Failure to Disconnect 20 20
Mechanical Problem 20 20
Material Discolored 17 17
Manufacturing, Packaging or Shipping Problem 16 16
Component Missing 15 15
Material Fragmentation 11 11
Loose or Intermittent Connection 11 11
Device Slipped 11 11
Compatibility Problem 10 10
Difficult to Remove 9 9
Physical Resistance/Sticking 9 9
Structural Problem 9 9
Off-Label Use 7 7
Improper or Incorrect Procedure or Method 7 7
Corroded 6 6
Use of Device Problem 6 6
Appropriate Term/Code Not Available 6 6
Deformation Due to Compressive Stress 5 5
Insufficient Information 4 4
Solder Joint Fracture 4 4
Connection Problem 3 3
Difficult to Insert 3 3
Nonstandard Device 3 3
Material Separation 3 3
Flaked 2 2
Dull, Blunt 2 2
Mechanics Altered 2 2
Device Damaged by Another Device 2 2
Failure to Cut 2 2
Fitting Problem 2 2
Device Handling Problem 1 1
Packaging Problem 1 1
Missing Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8200 8200
No Consequences Or Impact To Patient 1169 1169
Insufficient Information 1153 1153
No Code Available 162 162
No Known Impact Or Consequence To Patient 67 67
No Patient Involvement 40 40
Foreign Body In Patient 31 31
Not Applicable 21 21
Pain 4 4
Unspecified Infection 3 3
Failure of Implant 3 3
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 2 2
Bone Fracture(s) 2 2
Hematoma 1 1
Osteopenia/ Osteoporosis 1 1
Needle Stick/Puncture 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Enztec Limited II Jan-24-2020
2 Exactech, Inc. II Jun-30-2023
3 INCIPIO DEVICES II Nov-25-2024
4 XTANT Medical II Jul-04-2020
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