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TPLC
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Device
reamer
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HTO
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
1531
1531
2021
4802
4802
2022
3909
3909
2023
4403
4403
2024
4748
4748
2025
278
278
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
14556
14556
Naturally Worn
1904
1904
Break
1574
1574
Corroded
1040
1040
Device-Device Incompatibility
713
713
No Apparent Adverse Event
703
703
Material Twisted/Bent
503
503
Adverse Event Without Identified Device or Use Problem
444
444
Dull, Blunt
390
390
Entrapment of Device
359
359
Illegible Information
306
306
Contamination /Decontamination Problem
170
170
Material Deformation
166
166
Fracture
87
87
Crack
84
84
Detachment of Device or Device Component
53
53
Degraded
51
51
Mechanical Jam
50
50
Scratched Material
50
50
Material Integrity Problem
34
34
Device Contaminated During Manufacture or Shipping
33
33
Loose or Intermittent Connection
24
24
Unintended Movement
21
21
Improper or Incorrect Procedure or Method
20
20
Component Missing
15
15
Material Discolored
14
14
Appropriate Term/Code Not Available
12
12
Inaccurate Information
10
10
Structural Problem
9
9
Use of Device Problem
9
9
Physical Resistance/Sticking
7
7
Difficult to Insert
5
5
Material Fragmentation
4
4
Device Slipped
4
4
Defective Device
3
3
Material Disintegration
3
3
Peeled/Delaminated
3
3
Off-Label Use
3
3
Mechanical Problem
3
3
Difficult to Remove
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Product Quality Problem
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
2
2
Insufficient Information
2
2
Device Damaged Prior to Use
2
2
Difficult to Open or Remove Packaging Material
2
2
Difficult to Open or Close
2
2
Noise, Audible
2
2
Battery Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16953
16953
Insufficient Information
1384
1384
No Consequences Or Impact To Patient
959
959
Foreign Body In Patient
372
372
No Code Available
362
362
Not Applicable
42
42
Unspecified Tissue Injury
29
29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Injury
22
22
Limb Fracture
20
20
Bone Fracture(s)
18
18
No Patient Involvement
17
17
No Known Impact Or Consequence To Patient
8
8
Failure of Implant
6
6
Pain
6
6
Unspecified Infection
5
5
Septic Shock
5
5
Loss of Range of Motion
4
4
Shock
4
4
Hemorrhage/Bleeding
4
4
Post Operative Wound Infection
3
3
Device Embedded In Tissue or Plaque
3
3
Discomfort
2
2
Fall
2
2
Non-union Bone Fracture
2
2
Swelling/ Edema
2
2
Hip Fracture
1
1
Hematoma
1
1
Unspecified Nervous System Problem
1
1
Burn(s)
1
1
Nerve Damage
1
1
Laceration(s)
1
1
Hyperextension
1
1
Physical Entrapment
1
1
Perforation of Vessels
1
1
Tissue Damage
1
1
Skin Tears
1
1
Deformity/ Disfigurement
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes (USA) Products LLC
II
Mar-01-2024
2
Synthes (USA) Products LLC
II
Dec-15-2020
3
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
II
Mar-20-2020
4
Zimmer, Inc.
II
Feb-06-2023
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