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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device screwdriver
Product CodeHXX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 1644 1644
2021 2000 2000
2022 1721 1726
2023 1736 1736
2024 1715 1715

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3343 3343
Material Twisted/Bent 2201 2201
Device-Device Incompatibility 1321 1321
Fracture 752 752
Material Deformation 471 471
Naturally Worn 424 424
Material Integrity Problem 229 229
Contamination /Decontamination Problem 148 148
Entrapment of Device 125 125
Calibration Problem 125 125
Mechanical Jam 83 83
Crack 76 76
Compatibility Problem 69 69
Mechanical Problem 66 66
Detachment of Device or Device Component 64 64
Connection Problem 53 53
Material Fragmentation 43 43
Appropriate Term/Code Not Available 38 38
Unintended Movement 30 30
Use of Device Problem 27 27
Defective Device 26 26
No Apparent Adverse Event 25 25
Device Slipped 23 23
Material Separation 23 28
Physical Resistance/Sticking 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Corroded 14 14
Illegible Information 14 14
Component Missing 14 14
Scratched Material 14 14
Difficult to Remove 11 11
Loose or Intermittent Connection 9 9
Electrical /Electronic Property Problem 9 9
Device Difficult to Setup or Prepare 9 9
Degraded 8 8
Noise, Audible 7 7
Improper or Incorrect Procedure or Method 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Structural Problem 6 6
Activation, Positioning or Separation Problem 5 5
Mechanics Altered 5 5
Off-Label Use 5 5
Packaging Problem 5 5
Device Reprocessing Problem 5 5
Dull, Blunt 4 4
Fitting Problem 4 4
Device Damaged by Another Device 4 4
Incomplete or Inadequate Connection 4 4
Failure to Discharge 3 3
Deformation Due to Compressive Stress 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6688 6693
No Consequences Or Impact To Patient 851 851
Insufficient Information 562 562
Foreign Body In Patient 230 230
No Patient Involvement 226 226
No Known Impact Or Consequence To Patient 205 205
No Code Available 112 112
Device Embedded In Tissue or Plaque 62 62
No Information 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Not Applicable 16 16
Injury 16 16
Unspecified Tissue Injury 10 10
Failure of Implant 9 9
Hemorrhage/Bleeding 5 5
Blood Loss 3 3
Skull Fracture 2 2
Exsanguination 2 2
Bone Fracture(s) 2 2
Perforation 2 2
Perforation of Vessels 2 2
Unspecified Infection 1 1
Skin Inflammation/ Irritation 1 1
Ossification 1 1
Laceration(s) 1 1
Pain 1 1
Joint Laxity 1 1
Non-union Bone Fracture 1 1
Tissue Damage 1 1
Spinal Cord Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-19-2022
2 Flower Orthopedics Corporation II Jun-01-2021
3 Synthes (USA) Products LLC II May-28-2024
4 Trilliant Surgical, LLC II Jan-10-2020
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