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TPLC
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Device
reamer
Product Code
HTO
Regulation Number
888.4540
Device Class
1
Premarket Reviews
Manufacturer
Decision
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
404
404
2015
654
654
2016
1039
1039
2017
1234
1234
2018
1835
1835
2019
1955
1955
2020
1531
1531
2021
4802
4802
2022
3909
3909
2023
4405
4405
2024
1618
1618
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
12610
12610
Dull, Blunt
3744
3744
Break
2577
2577
Naturally Worn
2185
2185
Corroded
1731
1731
Material Twisted/Bent
712
712
Device-Device Incompatibility
691
691
Adverse Event Without Identified Device or Use Problem
560
560
Material Deformation
368
368
Appropriate Term/Code Not Available
330
330
Entrapment of Device
311
311
Illegible Information
287
287
Crack
209
209
Fracture
165
165
No Apparent Adverse Event
155
155
Material Fragmentation
137
137
Material Discolored
128
128
Contamination /Decontamination Problem
105
105
Mechanical Jam
92
92
Detachment of Device or Device Component
88
88
Device Operates Differently Than Expected
76
76
Scratched Material
75
75
Device Contamination with Chemical or Other Material
51
51
Pitted
47
47
Component Missing
47
47
Loose or Intermittent Connection
46
46
Degraded
43
43
Material Integrity Problem
34
34
Device Contaminated During Manufacture or Shipping
32
32
Insufficient Information
31
31
Fitting Problem
28
28
Bent
25
25
Detachment Of Device Component
25
25
Difficult to Insert
24
24
Unintended Movement
23
23
Physical Resistance/Sticking
23
23
Connection Problem
21
21
Material Erosion
17
17
Difficult to Remove
16
16
Improper or Incorrect Procedure or Method
16
16
Disassembly
15
15
Material Separation
14
14
Product Quality Problem
13
13
Use of Device Problem
13
13
Mechanical Problem
13
13
Device Slipped
10
10
Peeled/Delaminated
9
9
Sticking
9
9
Failure To Adhere Or Bond
7
7
Device Disinfection Or Sterilization Issue
7
7
Difficult to Open or Close
6
6
Component Falling
6
6
Device Reprocessing Problem
6
6
Metal Shedding Debris
6
6
Failure to Advance
6
6
Structural Problem
5
5
Device Damaged Prior to Use
5
5
Failure to Clean Adequately
5
5
Packaging Problem
4
4
Positioning Problem
4
4
Patient-Device Incompatibility
4
4
Off-Label Use
4
4
Separation Failure
4
4
Positioning Failure
4
4
Misconnection
4
4
Complete Blockage
3
3
Loss of or Failure to Bond
3
3
Failure to Align
3
3
Tear, Rip or Hole in Device Packaging
3
3
Defective Component
3
3
Device Inoperable
3
3
Difficult to Open or Remove Packaging Material
3
3
Device Dislodged or Dislocated
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Compatibility Problem
2
2
Material Distortion
2
2
Malposition of Device
2
2
Device Or Device Fragments Location Unknown
2
2
Battery Problem
2
2
Difficult to Advance
2
2
Device Difficult to Maintain
2
2
Device Handling Problem
2
2
Noise, Audible
2
2
Material Split, Cut or Torn
2
2
Problem with Sterilization
2
2
Inadequacy of Device Shape and/or Size
2
2
Cut In Material
2
2
Suction Problem
2
2
Defective Device
2
2
Difficult To Position
2
2
Delivered as Unsterile Product
2
2
Unintended Collision
2
2
Migration or Expulsion of Device
2
2
Misassembled
1
1
Hole In Material
1
1
Unsealed Device Packaging
1
1
Particulates
1
1
Monitor failure
1
1
Difficult or Delayed Positioning
1
1
Flaked
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14320
14320
No Consequences Or Impact To Patient
5273
5273
No Information
1165
1165
No Known Impact Or Consequence To Patient
1056
1056
Insufficient Information
641
641
No Code Available
586
586
Foreign Body In Patient
369
369
No Patient Involvement
306
306
Not Applicable
218
218
Device Embedded In Tissue or Plaque
163
163
Bone Fracture(s)
85
85
Sedation
55
55
Pain
42
42
Injury
35
35
Unspecified Infection
34
34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Blood Loss
19
19
Unspecified Tissue Injury
16
16
Non-union Bone Fracture
12
12
Failure of Implant
11
11
Limb Fracture
10
10
Embolism
6
6
Septic Shock
5
5
Tissue Damage
5
5
Shock
4
4
Tachycardia
4
4
Discomfort
4
4
Loss of Range of Motion
4
4
Hemorrhage/Bleeding
4
4
Hip Fracture
4
4
Impaired Healing
3
3
Post Operative Wound Infection
3
3
Low Blood Pressure/ Hypotension
3
3
Hematoma
3
3
Fall
2
2
Debris, Bone Shedding
2
2
Laceration(s)
2
2
Nerve Damage
2
2
Swelling
2
2
Patient Problem/Medical Problem
2
2
Inadequate Osseointegration
1
1
Alteration In Body Temperature
1
1
Test Result
1
1
Skin Tears
1
1
Reaction
1
1
Deformity/ Disfigurement
1
1
Joint Disorder
1
1
Hyperextension
1
1
Swelling/ Edema
1
1
Paresthesia
1
1
Unspecified Nervous System Problem
1
1
Perforation of Vessels
1
1
Physical Entrapment
1
1
Neurological Deficit/Dysfunction
1
1
Necrosis
1
1
Respiratory Distress
1
1
Staphylococcus Aureus
1
1
Foreign Body Reaction
1
1
Wound Dehiscence
1
1
Host-Tissue Reaction
1
1
Ossification
1
1
Pulmonary Embolism
1
1
Anemia
1
1
Arthritis
1
1
Bradycardia
1
1
Burn(s)
1
1
Cyst(s)
1
1
Death
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Nov-09-2018
2
Biomet, Inc.
II
May-26-2016
3
Biomet, Inc.
II
Oct-06-2014
4
Biomet, Inc.
II
Dec-04-2012
5
Biomet, Inc.
II
Mar-04-2011
6
Cayenne Medical Inc.
II
Jul-25-2018
7
DePuy Mitek, Inc., a Johnson & Johnson Co.
II
Dec-17-2012
8
DePuy Orthopaedics, Inc.
II
Mar-20-2013
9
Encore Medical, Lp
II
Aug-31-2017
10
Extremity Medical LLC
II
Nov-26-2012
11
Sterilmed Inc
II
Jan-13-2009
12
Stryker Howmedica Osteonics Corp.
II
May-17-2012
13
Stryker Howmedica Osteonics Corp.
II
Feb-17-2010
14
Synthes (USA) Products LLC
II
Mar-01-2024
15
Synthes (USA) Products LLC
II
Dec-15-2020
16
Synthes (USA) Products LLC
II
Mar-05-2018
17
Synthes (USA) Products LLC
II
Nov-23-2016
18
Synthes (USA) Products LLC
II
Nov-19-2016
19
Synthes (USA) Products LLC
II
Jun-06-2016
20
Synthes (USA) Products LLC
II
Jan-05-2016
21
Synthes (USA) Products LLC
II
Aug-10-2015
22
Synthes USA HQ, Inc.
II
Aug-12-2013
23
Synthes, Inc.
II
Jul-16-2015
24
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
II
Mar-20-2020
25
Trilliant Surgical Ltd.
II
Aug-24-2015
26
Zimmer, Inc.
II
Feb-06-2023
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