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TPLC
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show TPLC since
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Device
screwdriver
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HXX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
1644
1644
2021
2000
2000
2022
1721
1726
2023
1736
1736
2024
1715
1715
2025
315
315
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3558
3558
Material Twisted/Bent
2265
2265
Device-Device Incompatibility
1354
1354
Fracture
764
764
Material Deformation
478
478
Naturally Worn
427
427
Material Integrity Problem
233
233
Contamination /Decontamination Problem
149
149
Entrapment of Device
128
128
Calibration Problem
125
125
Mechanical Jam
83
83
Crack
77
77
Compatibility Problem
69
69
Mechanical Problem
66
66
Detachment of Device or Device Component
64
64
Connection Problem
53
53
Material Fragmentation
43
43
Appropriate Term/Code Not Available
38
38
Unintended Movement
30
30
Use of Device Problem
28
28
Defective Device
27
27
No Apparent Adverse Event
26
26
Material Separation
25
30
Device Slipped
24
24
Illegible Information
20
20
Physical Resistance/Sticking
19
19
Adverse Event Without Identified Device or Use Problem
17
17
Material Discolored
15
15
Component Missing
14
14
Corroded
14
14
Scratched Material
14
14
Difficult to Remove
11
11
Degraded
9
9
Loose or Intermittent Connection
9
9
Device Difficult to Setup or Prepare
9
9
Electrical /Electronic Property Problem
9
9
Improper or Incorrect Procedure or Method
7
7
Noise, Audible
7
7
Mechanics Altered
7
7
Activation, Positioning or Separation Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Structural Problem
6
6
Off-Label Use
5
5
Packaging Problem
5
5
Device Reprocessing Problem
5
5
Dull, Blunt
4
4
Fitting Problem
4
4
Device Damaged by Another Device
4
4
Incomplete or Inadequate Connection
4
4
Failure to Cut
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6962
6967
No Consequences Or Impact To Patient
851
851
Insufficient Information
599
599
Foreign Body In Patient
234
234
No Patient Involvement
226
226
No Known Impact Or Consequence To Patient
205
205
No Code Available
112
112
Device Embedded In Tissue or Plaque
62
62
No Information
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Injury
16
16
Not Applicable
16
16
Unspecified Tissue Injury
10
10
Failure of Implant
9
9
Hemorrhage/Bleeding
5
5
Blood Loss
3
3
Exsanguination
2
2
Perforation
2
2
Bone Fracture(s)
2
2
Skull Fracture
2
2
Perforation of Vessels
2
2
Spinal Cord Injury
1
1
Laceration(s)
1
1
Joint Laxity
1
1
Ossification
1
1
Skin Inflammation/ Irritation
1
1
Pain
1
1
Non-union Bone Fracture
1
1
Unspecified Infection
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-19-2022
2
Flower Orthopedics Corporation
II
Jun-01-2021
3
Synthes (USA) Products LLC
II
May-28-2024
4
Trilliant Surgical, LLC
II
Jan-10-2020
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