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TPLC
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show TPLC since
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Device
bit, drill
Product Code
HTW
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
1129
1129
2018
1241
1241
2019
1211
1211
2020
1244
1244
2021
1577
1577
2022
504
504
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3843
3843
Failure to Cut
562
562
Fracture
468
468
Entrapment of Device
432
432
Material Twisted/Bent
417
417
Device-Device Incompatibility
354
354
Material Deformation
352
352
Dull, Blunt
324
324
Bent
174
174
Material Fragmentation
140
140
Naturally Worn
113
113
Mechanical Jam
72
72
Device Operates Differently Than Expected
71
71
Appropriate Term/Code Not Available
68
68
Corroded
59
59
Adverse Event Without Identified Device or Use Problem
49
49
Detachment of Device or Device Component
42
42
Insufficient Information
35
35
Detachment Of Device Component
35
35
Physical Resistance/Sticking
32
32
Contamination /Decontamination Problem
32
32
Illegible Information
31
31
Crack
31
31
Difficult to Remove
29
29
Component Missing
28
28
Material Integrity Problem
26
26
Mechanical Problem
23
23
Use of Device Problem
22
22
Packaging Problem
20
20
Delivered as Unsterile Product
18
18
Failure to Align
17
17
Scratched Material
17
17
Improper or Incorrect Procedure or Method
16
16
Degraded
16
16
Separation Failure
15
15
Device Contaminated During Manufacture or Shipping
14
14
Unintended Movement
13
13
Device Contamination with Chemical or Other Material
12
12
Material Separation
12
12
Overheating of Device
10
10
Incorrect Measurement
9
9
Tear, Rip or Hole in Device Packaging
8
8
Structural Problem
7
7
Difficult to Insert
7
7
Defective Device
6
6
Connection Problem
6
6
Device Markings/Labelling Problem
5
5
Temperature Problem
5
5
Flaked
5
5
Product Quality Problem
5
5
Nonstandard Device
4
4
Loose or Intermittent Connection
4
4
Residue After Decontamination
4
4
Fitting Problem
4
4
Device Handling Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
No Apparent Adverse Event
4
4
Device Fell
3
3
Device Packaging Compromised
3
3
Device Difficult to Maintain
3
3
Mechanics Altered
3
3
Device Slipped
3
3
Unraveled Material
3
3
Device Issue
3
3
Loss of or Failure to Bond
3
3
Component Falling
3
3
Material Disintegration
2
2
Difficult or Delayed Positioning
2
2
Failure to Advance
2
2
Expiration Date Error
2
2
Patient-Device Incompatibility
2
2
Failure to Disconnect
2
2
Unstable
2
2
Device Inoperable
2
2
Metal Shedding Debris
2
2
Patient Device Interaction Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Deformation Due to Compressive Stress
2
2
Device Operational Issue
2
2
Difficult to Advance
2
2
Device Dislodged or Dislocated
1
1
Human-Device Interface Problem
1
1
Device Damaged by Another Device
1
1
Activation, Positioning or SeparationProblem
1
1
Torn Material
1
1
Physical Property Issue
1
1
Positioning Problem
1
1
Material Split, Cut or Torn
1
1
Excessive Heating
1
1
Difficult or Delayed Separation
1
1
Inaccurate Information
1
1
Vibration
1
1
Defective Component
1
1
Incomplete or Missing Packaging
1
1
Smoking
1
1
Sticking
1
1
Shelf Life Exceeded
1
1
Inadequacy of Device Shape and/or Size
1
1
Battery Problem
1
1
Device Or Device Fragments Location Unknown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
2316
2316
No Clinical Signs, Symptoms or Conditions
1825
1825
Foreign Body In Patient
755
755
No Known Impact Or Consequence To Patient
633
633
No Information
453
453
No Code Available
380
380
Device Embedded In Tissue or Plaque
316
316
No Patient Involvement
251
251
Not Applicable
166
166
Insufficient Information
142
142
Injury
69
69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Bone Fracture(s)
15
15
Failure of Implant
12
12
Burn(s)
10
10
Pain
8
8
Patient Problem/Medical Problem
7
7
Unspecified Tissue Injury
7
7
Tissue Damage
6
6
Hemorrhage/Bleeding
6
6
Unspecified Infection
5
5
Hematoma
4
4
Paralysis
3
3
Laceration(s)
3
3
Impaired Healing
3
3
Blood Loss
3
3
Perforation of Vessels
2
2
Discomfort
2
2
Swelling
2
2
Synovitis
1
1
Nerve Damage
1
1
Pneumothorax
1
1
Loss of Range of Motion
1
1
Spinal Column Injury
1
1
Death
1
1
Fever
1
1
Infiltration into Tissue
1
1
Vessel Or Plaque, Device Embedded In
1
1
Chills
1
1
Burn, Thermal
1
1
Hip Fracture
1
1
Deformity/ Disfigurement
1
1
Thromboembolism
1
1
Ischemia Stroke
1
1
Limb Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AAP Implantate Ag
III
Dec-22-2019
2
Arthrex, Inc.
II
Mar-26-2021
3
Biomet, Inc.
II
Dec-17-2020
4
Cayenne Medical Inc.
II
Jul-28-2018
5
Flower Orthopedics Corporation
II
Oct-14-2021
6
MicroAire Surgical Instruments, LLC
II
Jan-26-2018
7
NEOSTEO
II
Aug-09-2021
8
Paragon 28, Inc.
II
Sep-17-2021
9
Tornier, Inc
II
May-09-2018
10
Trilliant Surgical, LLC
II
May-05-2020
11
Zimmer GmbH
II
May-23-2019
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