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TPLC
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show TPLC since
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Device
reamer
Product Code
HTO
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
1835
1835
2019
1954
1954
2020
1531
1531
2021
4805
4805
2022
3926
3926
2023
1405
1405
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
8889
8889
Dull, Blunt
2325
2325
Break
1527
1527
Corroded
1140
1140
Naturally Worn
1085
1085
Material Twisted/Bent
705
705
Adverse Event Without Identified Device or Use Problem
480
480
Device-Device Incompatibility
460
460
Material Deformation
318
318
Illegible Information
278
278
Entrapment of Device
254
254
Crack
168
168
Appropriate Term/Code Not Available
104
104
Material Discolored
95
95
Fracture
91
91
Contamination /Decontamination Problem
90
90
No Apparent Adverse Event
89
89
Scratched Material
66
66
Mechanical Jam
58
58
Detachment of Device or Device Component
50
50
Device Contamination with Chemical or Other Material
47
47
Loose or Intermittent Connection
41
41
Pitted
38
38
Degraded
31
31
Device Contaminated During Manufacture or Shipping
30
30
Material Integrity Problem
25
25
Physical Resistance/Sticking
23
23
Component Missing
21
21
Difficult to Insert
19
19
Material Erosion
15
15
Unintended Movement
14
14
Material Fragmentation
13
13
Improper or Incorrect Procedure or Method
12
12
Connection Problem
11
11
Product Quality Problem
9
9
Mechanical Problem
9
9
Device Slipped
8
8
Peeled/Delaminated
7
7
Device Disinfection Or Sterilization Issue
7
7
Use of Device Problem
7
7
Difficult to Open or Close
6
6
Difficult to Remove
6
6
Device Operates Differently Than Expected
5
5
Failure to Clean Adequately
5
5
Insufficient Information
4
4
Device Damaged Prior to Use
4
4
Patient-Device Incompatibility
4
4
Failure to Advance
4
4
Off-Label Use
4
4
Positioning Failure
4
4
Bent
4
4
Detachment Of Device Component
3
3
Defective Component
3
3
Structural Problem
3
3
Positioning Problem
3
3
Noise, Audible
2
2
Material Split, Cut or Torn
2
2
Device Difficult to Maintain
2
2
Packaging Problem
2
2
Defective Device
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Loss of or Failure to Bond
2
2
Delivered as Unsterile Product
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
2
2
Problem with Sterilization
2
2
Fitting Problem
2
2
Device Stops Intermittently
1
1
Particulates
1
1
Material Puncture/Hole
1
1
Difficult To Position
1
1
Difficult or Delayed Positioning
1
1
Misassembled
1
1
Hole In Material
1
1
Compatibility Problem
1
1
Measurement System Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Device Dislodged or Dislocated
1
1
Electrical Power Problem
1
1
Difficult to Advance
1
1
Device Tipped Over
1
1
Dent in Material
1
1
Separation Failure
1
1
Battery Problem
1
1
Communication or Transmission Problem
1
1
Cut In Material
1
1
Device Issue
1
1
Overfill
1
1
Optical Discoloration
1
1
Output below Specifications
1
1
Device Handling Problem
1
1
Device Fell
1
1
Incomplete or Inadequate Connection
1
1
Separation Problem
1
1
Misassembled During Installation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
9971
9971
No Consequences Or Impact To Patient
4137
4137
No Code Available
459
459
Insufficient Information
393
393
Foreign Body In Patient
304
304
Not Applicable
217
217
No Known Impact Or Consequence To Patient
120
120
No Patient Involvement
115
115
Bone Fracture(s)
63
63
Pain
32
32
Injury
31
31
No Information
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
23
23
Unspecified Infection
19
19
Blood Loss
18
18
Device Embedded In Tissue or Plaque
13
13
Unspecified Tissue Injury
12
12
Non-union Bone Fracture
11
11
Limb Fracture
8
8
Failure of Implant
6
6
Septic Shock
5
5
Shock
4
4
Low Blood Pressure/ Hypotension
3
3
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Embolism
2
2
Loss of Range of Motion
2
2
Nerve Damage
2
2
Discomfort
2
2
Patient Problem/Medical Problem
2
2
Unspecified Nervous System Problem
1
1
Joint Disorder
1
1
Skin Tears
1
1
Hip Fracture
1
1
Physical Entrapment
1
1
Neurological Deficit/Dysfunction
1
1
Laceration(s)
1
1
Respiratory Distress
1
1
Tissue Damage
1
1
Fall
1
1
Pulmonary Embolism
1
1
Anemia
1
1
Bradycardia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Nov-09-2018
2
Cayenne Medical Inc.
II
Jul-25-2018
3
Synthes (USA) Products LLC
II
Dec-15-2020
4
Synthes (USA) Products LLC
II
Mar-05-2018
5
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
II
Mar-20-2020
6
Zimmer, Inc.
II
Feb-06-2023
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