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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, drill
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 1245 1245
2021 1569 1569
2022 1519 1519
2023 1773 1773
2024 1435 1435
2025 613 613

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4525 4525
Failure to Cut 1063 1063
Entrapment of Device 768 768
Material Deformation 639 639
Fracture 623 623
Device-Device Incompatibility 594 594
Naturally Worn 233 233
Material Twisted/Bent 186 186
Dull, Blunt 123 123
Material Integrity Problem 96 96
Mechanical Jam 92 92
Contamination /Decontamination Problem 66 66
No Apparent Adverse Event 56 56
Physical Resistance/Sticking 45 45
Material Fragmentation 39 39
Illegible Information 38 38
Adverse Event Without Identified Device or Use Problem 37 37
Degraded 34 34
Appropriate Term/Code Not Available 30 30
Corroded 29 29
Improper or Incorrect Procedure or Method 23 23
Detachment of Device or Device Component 20 20
Scratched Material 17 17
Device Contaminated During Manufacture or Shipping 15 15
Material Separation 14 14
Use of Device Problem 14 14
Difficult to Remove 14 14
Overheating of Device 13 13
Structural Problem 13 13
Mechanical Problem 13 13
Crack 13 13
Component Missing 12 12
Protective Measures Problem 10 10
Packaging Problem 10 10
Insufficient Information 7 7
Difficult to Advance 7 7
Separation Failure 6 6
Device Dislodged or Dislocated 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Noise, Audible 5 5
Flaked 5 5
Unintended Movement 5 5
Activation, Positioning or Separation Problem 4 4
Smoking 4 4
Patient Device Interaction Problem 4 4
Difficult to Insert 4 4
Device Markings/Labelling Problem 4 4
Delivered as Unsterile Product 4 4
Therapeutic or Diagnostic Output Failure 3 3
Inaccurate Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5432 5432
Insufficient Information 946 946
Foreign Body In Patient 904 904
No Consequences Or Impact To Patient 724 724
No Code Available 192 192
Device Embedded In Tissue or Plaque 166 166
No Known Impact Or Consequence To Patient 69 69
No Patient Involvement 43 43
Not Applicable 41 41
Injury 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
No Information 18 18
Unspecified Tissue Injury 17 17
Bone Fracture(s) 15 15
Failure of Implant 12 12
Hemorrhage/Bleeding 6 6
Perforation 5 5
Burn(s) 5 5
Pain 5 5
Unspecified Infection 4 4
Tissue Damage 3 3
Impaired Healing 2 2
Hypersensitivity/Allergic reaction 2 2
Nerve Damage 2 2
Discomfort 2 2
Perforation of Vessels 2 2
Vertebral Fracture 1 1
Ischemia Stroke 1 1
Full thickness (Third Degree) Burn 1 1
Low Oxygen Saturation 1 1
Arthritis 1 1
Thromboembolism 1 1
Deformity/ Disfigurement 1 1
Bacterial Infection 1 1
Swelling/ Edema 1 1
Limb Fracture 1 1
Laceration(s) 1 1
Osteolysis 1 1
Loss of Range of Motion 1 1
Osteomyelitis 1 1
Chills 1 1
Fever 1 1
Foreign Body Reaction 1 1
Blood Loss 1 1
Rupture 1 1
Hematoma 1 1
Unspecified Musculoskeletal problem 1 1
Vascular Dissection 1 1
Necrosis 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Mar-26-2021
2 Biomet, Inc. II Dec-17-2020
3 Flower Orthopedics Corporation II Oct-14-2021
4 NEOSTEO II Aug-09-2021
5 Paragon 28, Inc. II Sep-17-2021
6 Trilliant Surgical, LLC II May-05-2020
7 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-06-2024
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