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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic manual surgical instrument
Product CodeLXH
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
SONEX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4687 4687
2019 5224 5233
2020 4767 4772
2021 4846 4897
2022 4854 4922

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9700 9700
Device-Device Incompatibility 2867 2867
Fracture 2260 2284
Material Twisted/Bent 1224 1224
Material Deformation 1222 1254
Crack 1072 1072
Naturally Worn 866 866
Scratched Material 826 826
Mechanical Jam 744 788
Detachment of Device or Device Component 743 743
Mechanical Problem 579 579
Adverse Event Without Identified Device or Use Problem 408 410
Calibration Problem 400 400
Appropriate Term/Code Not Available 350 350
Material Fragmentation 313 313
Corroded 285 285
Material Integrity Problem 276 276
Difficult to Remove 237 237
Physical Resistance/Sticking 222 222
Component Missing 217 217
Loose or Intermittent Connection 213 213
Mechanics Altered 210 210
Contamination /Decontamination Problem 191 191
Entrapment of Device 183 183
Connection Problem 145 145
Illegible Information 141 141
Device Operates Differently Than Expected 136 136
Unintended Movement 135 135
Insufficient Information 132 132
Use of Device Problem 128 128
Dull, Blunt 119 119
Compatibility Problem 117 117
Device Contamination with Chemical or Other Material 116 116
Difficult to Open or Close 107 107
Failure to Align 105 105
Material Discolored 103 103
Material Separation 93 93
Bent 89 89
Degraded 83 83
Device Slipped 81 81
Defective Device 75 75
Difficult to Insert 67 67
Detachment Of Device Component 66 66
Positioning Failure 63 63
Material Split, Cut or Torn 59 59
Separation Failure 52 52
No Apparent Adverse Event 50 50
Positioning Problem 49 49
Flaked 49 49
Device Damaged Prior to Use 47 47
Device Dislodged or Dislocated 45 45
Fitting Problem 44 44
Failure to Advance 43 43
Difficult to Advance 42 42
Deformation Due to Compressive Stress 39 50
Peeled/Delaminated 37 37
Material Disintegration 34 34
Device Damaged by Another Device 33 33
Improper or Incorrect Procedure or Method 33 33
Device Markings/Labelling Problem 32 32
Device Fell 30 30
Difficult or Delayed Separation 28 28
Solder Joint Fracture 28 28
Metal Shedding Debris 26 26
Unstable 26 26
Device Difficult to Setup or Prepare 23 23
Incomplete or Inadequate Connection 23 23
Activation, Positioning or Separation Problem 23 23
Display Difficult to Read 22 22
Defective Component 22 22
Failure to Cut 22 22
Structural Problem 21 21
Inadequacy of Device Shape and/or Size 20 20
Difficult or Delayed Positioning 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Migration 19 19
Nonstandard Device 19 19
Device Issue 19 19
Failure to Disconnect 19 19
Residue After Decontamination 18 18
Migration or Expulsion of Device 18 18
Patient Device Interaction Problem 18 18
Device Difficult to Maintain 18 18
Device Contaminated During Manufacture or Shipping 18 18
Separation Problem 17 17
Device Reprocessing Problem 17 17
Delivered as Unsterile Product 16 16
Failure to Clean Adequately 16 16
Failure to Eject 16 42
Output Problem 15 15
Problem with Sterilization 15 15
Patient-Device Incompatibility 14 14
Incorrect Measurement 13 13
Device Handling Problem 13 13
Device Operational Issue 12 12
Device Inoperable 12 12
Sticking 11 11
Material Protrusion/Extrusion 11 11
Packaging Problem 10 10
Loosening of Implant Not Related to Bone-Ingrowth 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9505 9624
No Consequences Or Impact To Patient 8274 8288
No Known Impact Or Consequence To Patient 2508 2508
No Patient Involvement 1019 1019
No Code Available 814 814
Foreign Body In Patient 716 716
Insufficient Information 526 528
Not Applicable 467 467
No Information 365 365
Device Embedded In Tissue or Plaque 353 353
Bone Fracture(s) 145 145
Injury 130 130
Failure of Implant 83 83
Pain 81 81
Unspecified Infection 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Tissue Damage 52 52
Unspecified Tissue Injury 40 40
Nerve Damage 21 21
Loss of Range of Motion 20 20
Laceration(s) 16 16
Non-union Bone Fracture 16 16
Patient Problem/Medical Problem 15 15
Inflammation 15 15
Hemorrhage/Bleeding 15 15
Pulmonary Embolism 14 14
Death 13 13
Blood Loss 12 12
Hip Fracture 12 12
Discomfort 10 10
Joint Dislocation 8 8
Post Operative Wound Infection 8 8
Limb Fracture 8 8
Paralysis 8 8
Perforation of Vessels 8 8
Weakness 7 7
Scar Tissue 7 7
Implant Pain 7 7
Fluid Discharge 7 7
Ambulation Difficulties 7 7
Rupture 6 6
Swelling/ Edema 6 6
Joint Laxity 6 6
Perforation 6 6
Necrosis 5 5
Spinal Column Injury 5 5
Neurological Deficit/Dysfunction 5 5
Bacterial Infection 5 5
Osteolysis 5 5
Impaired Healing 5 5
Reaction 5 5
Arthralgia 5 5
Disc Impingement 5 5
Spinal Cord Injury 5 5
Inadequate Osseointegration 4 4
Deformity/ Disfigurement 4 4
Numbness 4 4
Swelling 4 4
Limited Mobility Of The Implanted Joint 4 4
Burn(s) 4 4
Cardiac Arrest 4 4
Muscular Rigidity 4 4
Foreign Body Reaction 4 4
Hematoma 4 4
Infiltration into Tissue 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Muscle Weakness 3 3
Neuropathy 3 3
Local Reaction 3 3
Arthritis 3 3
Vessel Or Plaque, Device Embedded In 3 3
Abscess 3 3
Adhesion(s) 3 3
Purulent Discharge 3 3
Muscle/Tendon Damage 3 3
Osteopenia/ Osteoporosis 3 3
Skin Irritation 3 3
Joint Disorder 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Intraoperative Pain 2 2
Synovitis 2 2
Thrombosis 2 2
Unspecified Musculoskeletal problem 2 2
External Prosthetic Device Pain 2 2
Malunion of Bone 2 2
Hyperextension 2 2
Subluxation 2 2
Physical Asymmetry 2 2
Unintended Radiation Exposure 2 2
Dysphagia/ Odynophagia 2 2
Exsanguination 2 2
Extravasation 2 2
Headache 2 2
Fall 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
Rash 2 2
Internal Organ Perforation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II May-25-2018
2 Aesculap Implant Systems LLC II Jul-21-2022
3 Aesculap Implant Systems LLC II Jul-21-2022
4 Aesculap Implant Systems LLC II Jul-15-2022
5 Arthrex, Inc. II May-05-2022
6 Arthrex, Inc. II Jan-30-2020
7 Biomet II Jun-12-2020
8 ConMed Corporation II Apr-27-2021
9 ConMed Corporation II Dec-21-2020
10 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
12 DePuy Orthopaedics, Inc. II Apr-11-2019
13 DePuy Orthopaedics, Inc. II Mar-02-2018
14 Encore Medical, Lp II Dec-06-2019
15 Exactech, Inc. II Oct-11-2018
16 Howmedica Osteonics Corp. II Dec-21-2018
17 Howmedica Osteonics Corp. II Nov-02-2018
18 Howmedica Osteonics Corp. II Oct-23-2018
19 Howmedica Osteonics Corp. II Mar-01-2018
20 In2bones USA, LLC II Sep-22-2021
21 K2M, Inc II Dec-07-2020
22 Laboratoires Bodycad, Inc. II Nov-17-2021
23 Medacta Usa Inc II Jun-07-2022
24 Mizuho OSI II Aug-24-2022
25 OMNIlife science Inc. II Feb-14-2019
26 Pega Medical Inc. III May-15-2020
27 Pega Medical Inc. II Nov-01-2019
28 SONEX HEALTH LLC II Jul-15-2022
29 Smith & Nephew, Inc. II Aug-10-2020
30 Smith & Nephew, Inc. II Nov-08-2019
31 Smith & Nephew, Inc. II Jan-12-2019
32 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
33 Synthes (USA) Products LLC II Feb-10-2022
34 Synthes, Inc. II Apr-24-2018
35 TeDan Surgical Innovations LLC II Jul-10-2020
36 TeDan Surgical Innovations LLC II Mar-17-2020
37 Tornier, Inc II Jun-01-2022
38 TriMed Inc. II Nov-12-2019
39 TriMed Inc. II Apr-12-2018
40 Zimmer Biomet, Inc. II Jun-02-2020
41 Zimmer Biomet, Inc. II Jan-28-2020
42 Zimmer Biomet, Inc. II Dec-03-2019
43 Zimmer Biomet, Inc. II Nov-22-2019
44 Zimmer Biomet, Inc. II Nov-07-2019
45 Zimmer Biomet, Inc. II Jul-04-2019
46 Zimmer Biomet, Inc. II Jun-19-2019
47 Zimmer Biomet, Inc. II Jun-06-2019
48 Zimmer Biomet, Inc. II Nov-30-2018
49 Zimmer Biomet, Inc. II Aug-18-2018
50 Zimmer Biomet, Inc. II Aug-17-2018
51 Zimmer Biomet, Inc. II Apr-20-2018
52 Zimmer Biomet, Inc. II Mar-28-2018
53 Zimmer Biomet, Inc. II Mar-06-2018
54 Zimmer Biomet, Inc. II Feb-27-2018
55 Zimmer Biomet, Inc. II Feb-07-2018
56 Zimmer Biomet, Inc. II Feb-04-2018
57 restor3d Inc. II Apr-29-2022
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