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TPLC
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Device
broach
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HTQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
466
466
2021
550
550
2022
506
506
2023
586
586
2024
477
477
2025
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
1205
1205
Break
459
459
Unintended Movement
273
273
Failure to Cut
238
238
Material Deformation
183
183
Naturally Worn
154
154
Scratched Material
133
133
Difficult to Advance
116
116
Adverse Event Without Identified Device or Use Problem
79
79
Structural Problem
75
75
Material Twisted/Bent
70
70
Fracture
45
45
Device Damaged Prior to Use
44
44
No Apparent Adverse Event
42
42
Material Integrity Problem
38
38
Dull, Blunt
33
33
Contamination /Decontamination Problem
31
31
Chemical Problem
29
29
Mechanical Jam
27
27
Loose or Intermittent Connection
25
25
Illegible Information
25
25
Physical Resistance/Sticking
24
24
Inadequacy of Device Shape and/or Size
24
24
Device Slipped
19
19
Missing Information
16
16
Difficult to Open or Close
16
16
Entrapment of Device
14
14
Detachment of Device or Device Component
11
11
Crack
10
10
Device Dislodged or Dislocated
10
10
Device Contaminated During Manufacture or Shipping
9
9
Tear, Rip or Hole in Device Packaging
7
7
Device Markings/Labelling Problem
6
6
Off-Label Use
4
4
Corroded
4
4
Defective Device
3
3
Device Damaged by Another Device
3
3
Use of Device Problem
3
3
Difficult to Remove
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Material Discolored
1
1
Component Missing
1
1
Positioning Problem
1
1
Noise, Audible
1
1
Backflow
1
1
Mechanical Problem
1
1
Material Frayed
1
1
Difficult to Open or Remove Packaging Material
1
1
Appropriate Term/Code Not Available
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1830
1830
No Consequences Or Impact To Patient
338
338
Insufficient Information
318
318
No Code Available
137
137
Bone Fracture(s)
26
26
Limb Fracture
25
25
Not Applicable
19
19
No Known Impact Or Consequence To Patient
18
18
Unspecified Tissue Injury
16
16
Pain
11
11
Joint Dislocation
10
10
Unspecified Infection
8
8
Joint Laxity
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Patient Involvement
3
3
Foreign Body In Patient
3
3
Loss of Range of Motion
2
2
No Information
2
2
Deformity/ Disfigurement
1
1
Thrombosis/Thrombus
1
1
Nerve Damage
1
1
Foreign Body Reaction
1
1
Physical Asymmetry
1
1
Fall
1
1
Distress
1
1
Damage to Ligament(s)
1
1
Fatigue
1
1
Low Blood Pressure/ Hypotension
1
1
Scar Tissue
1
1
Discomfort
1
1
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