Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
bit, drill
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HTW
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
-
-