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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
Regulation Description 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
2016 6359 6359
2017 4132 4132
2018 4687 4687
2019 5224 5233
2020 4766 4771
2021 3234 3282

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12585 12585
Fracture 2342 2346
Device-Device Incompatibility 1895 1895
Crack 1371 1371
Appropriate Term/Code Not Available 1164 1164
Material Twisted/Bent 1160 1160
Material Deformation 964 979
Scratched Material 820 820
Mechanical Jam 773 805
Naturally Worn 725 725
Mechanical Problem 591 591
Device Operates Differently Than Expected 500 500
Material Fragmentation 473 473
Detachment of Device or Device Component 457 457
Dull, Blunt 428 428
Material Integrity Problem 404 404
Adverse Event Without Identified Device or Use Problem 397 397
Component Missing 382 382
Detachment Of Device Component 330 330
Bent 325 325
Corroded 321 321
Difficult to Remove 312 312
Insufficient Information 289 289
Calibration Problem 264 264
Loose or Intermittent Connection 256 256
Physical Resistance/Sticking 207 207
Failure to Align 204 204
Fitting Problem 198 198
Connection Problem 195 195
Entrapment of Device 156 156
Device Contamination with Chemical or Other Material 154 154
Illegible Information 142 142
Material Discolored 141 141
Mechanics Altered 127 127
Contamination /Decontamination Problem 113 113
Disassembly 111 111
Unintended Movement 95 95
Use of Device Problem 94 94
Difficult to Insert 92 92
Separation Failure 82 82
Defective Device 82 82
Device Slipped 81 81
Device Dislodged or Dislocated 78 78
Material Separation 76 76
Device Reprocessing Problem 76 76
Degraded 68 68
Positioning Problem 68 68
Compatibility Problem 67 67
Sticking 67 67
Difficult to Open or Close 60 60
Failure to Advance 57 57
Metal Shedding Debris 53 53
Positioning Failure 52 52
Device Damaged Prior to Use 51 51
Peeled/Delaminated 51 51
Failure To Adhere Or Bond 49 49
Device Damaged by Another Device 46 46
Nonstandard Device 42 42
Device Markings/Labelling Problem 42 42
Improper or Incorrect Procedure or Method 39 39
Device Issue 37 37
Material Disintegration 34 34
Misconnection 34 34
Defective Component 33 33
Residue After Decontamination 32 32
Device Inoperable 32 32
Difficult to Advance 32 32
No Apparent Adverse Event 32 32
Component Falling 31 31
Device Operational Issue 29 29
Device Or Device Fragments Location Unknown 29 29
Deformation Due to Compressive Stress 29 40
Failure to Disconnect 28 28
Migration or Expulsion of Device 27 27
Material Split, Cut or Torn 26 26
Device Fell 26 26
Incomplete or Inadequate Connection 23 23
Solder Joint Fracture 23 23
Malposition of Device 23 23
Packaging Problem 23 23
Difficult To Position 23 23
Failure to Cut 22 22
Unstable 22 22
Display Difficult to Read 22 22
Manufacturing, Packaging or Shipping Problem 22 22
Device Difficult to Maintain 21 21
Flaked 21 21
Difficult or Delayed Separation 21 21
Activation, Positioning or SeparationProblem 20 20
Incorrect Measurement 20 20
Inadequacy of Device Shape and/or Size 20 20
Difficult or Delayed Positioning 19 19
Device Handling Problem 19 19
Delivered as Unsterile Product 18 18
Split 16 16
Problem with Sterilization 15 15
Patient Device Interaction Problem 15 15
Patient-Device Incompatibility 15 15
Failure to Clean Adequately 15 15
Material Protrusion/Extrusion 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9339 9353
No Known Impact Or Consequence To Patient 8038 8038
No Clinical Signs, Symptoms or Conditions 3755 3805
No Information 3086 3086
No Patient Involvement 1495 1495
No Code Available 1082 1082
Foreign Body In Patient 697 697
Device Embedded In Tissue or Plaque 654 654
Not Applicable 496 496
Insufficient Information 221 221
Bone Fracture(s) 196 196
Injury 174 174
Unspecified Infection 96 96
Pain 86 86
Failure of Implant 76 76
Tissue Damage 69 69
Sedation 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Unspecified Tissue Injury 26 26
Blood Loss 25 25
Hip Fracture 19 19
Patient Problem/Medical Problem 16 16
Death 16 16
Non-union Bone Fracture 14 14
Pulmonary Embolism 14 14
Inflammation 13 13
Loss of Range of Motion 13 13
Hemorrhage/Bleeding 12 12
Joint Disorder 11 11
Discomfort 10 10
Paralysis 9 9
Swelling 9 9
Joint Dislocation 8 8
Nerve Damage 8 8
Foreign Body Reaction 8 8
Laceration(s) 8 8
Weakness 8 8
Reaction 8 8
Post Operative Wound Infection 8 8
Impaired Healing 7 7
Ambulation Difficulties 7 7
Perforation of Vessels 6 6
Perforation 6 6
Burn(s) 6 6
Bacterial Infection 6 6
Disc Impingement 5 5
Necrosis 5 5
Limited Mobility Of The Implanted Joint 5 5
Neurological Deficit/Dysfunction 5 5
Fluid Discharge 5 5
Spinal Column Injury 4 4
Fall 4 4
Hematoma 4 4
Vessel Or Plaque, Device Embedded In 4 4
Arthritis 4 4
Synovitis 4 4
Local Reaction 4 4
Scar Tissue 4 4
Arthralgia 4 4
Cardiac Arrest 4 4
Muscular Rigidity 4 4
Myocardial Infarction 3 3
Complaint, Ill-Defined 3 3
Inadequate Osseointegration 3 3
Nervous System Injury 3 3
Limb Fracture 3 3
Joint Laxity 3 3
Abscess 3 3
Cerebrospinal Fluid Leakage 3 3
Erythema 3 3
Irritation 3 3
Rupture 3 3
Skin Irritation 3 3
Osteolysis 3 3
Numbness 2 2
Loss of consciousness 2 2
Spinal Cord Injury 2 2
Thrombosis 2 2
Deformity/ Disfigurement 2 2
Muscle Weakness 2 2
Hypersensitivity/Allergic reaction 2 2
Fever 2 2
Rash 2 2
Exsanguination 2 2
Extravasation 2 2
Dysphagia/ Odynophagia 2 2
Awareness during Anaesthesia 2 2
External Prosthetic Device Pain 2 2
Radiation Exposure, Unintended 2 2
Intraoperative Pain 2 2
Burning Sensation 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Damage to Ligament(s) 2 2
Itching Sensation 2 2
Incontinence 2 2
Debris, Bone Shedding 2 2
Eye Injury 2 2
Fistula 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Mar-16-2017
2 Ad-Tech Medical Instrument Corporation II May-25-2018
3 Amendia, Inc II Apr-25-2017
4 Amendia, Inc II Dec-22-2016
5 Arthrex, Inc. II Jan-30-2020
6 Biomet II Jun-12-2020
7 Biomet U.K., Ltd. II Feb-22-2017
8 Biomet, Inc. II May-26-2016
9 Biomet, Inc. II Feb-25-2016
10 Cardinal Health 200, LLC II Oct-11-2016
11 ConMed Corporation II Apr-27-2021
12 ConMed Corporation II Dec-21-2020
13 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
14 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
15 DePuy Orthopaedics, Inc. II Apr-11-2019
16 DePuy Orthopaedics, Inc. II Mar-02-2018
17 DePuy Orthopaedics, Inc. II Jun-08-2017
18 Encore Medical, Lp II Dec-06-2019
19 Exactech, Inc. II Oct-11-2018
20 Exactech, Inc. II Jun-19-2017
21 Exactech, Inc. II Jun-19-2017
22 Flower Orthopedics Corporation II Jan-28-2017
23 Greatbatch Medical II Feb-11-2017
24 Howmedica Osteonics Corp. II Dec-21-2018
25 Howmedica Osteonics Corp. II Nov-02-2018
26 Howmedica Osteonics Corp. II Oct-23-2018
27 Howmedica Osteonics Corp. II Mar-01-2018
28 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
29 In2bones USA, LLC II Sep-22-2021
30 K2M, Inc II Dec-07-2020
31 LDR Spine USA, Inc. II Oct-05-2016
32 Limacorporate S.p.A II Nov-06-2017
33 Limacorporate S.p.A II Aug-31-2016
34 MEDLINE INDUSTRIES INC II May-17-2017
35 Medtronic Sofamor Danek USA Inc II May-05-2017
36 OMNIlife science Inc. II Feb-14-2019
37 Pega Medical Inc. III May-15-2020
38 Pega Medical Inc. II Nov-01-2019
39 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
40 Smith & Nephew, Inc. II Aug-10-2020
41 Smith & Nephew, Inc. II Nov-08-2019
42 Smith & Nephew, Inc. II Jan-12-2019
43 Stryker Howmedica Osteonics Corp. II Jan-12-2017
44 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
45 Stryker Spine II Feb-19-2016
46 Synthes (USA) Products LLC II Feb-27-2017
47 Synthes (USA) Products LLC II Nov-19-2016
48 Synthes, Inc. II Apr-24-2018
49 TeDan Surgical Innovations LLC II Jul-10-2020
50 TeDan Surgical Innovations LLC II Mar-17-2020
51 Thayer Intellectual Property, Inc. II Dec-03-2016
52 TriMed Inc. II Nov-12-2019
53 TriMed Inc. II Apr-12-2018
54 United Orthopedic Corporation II Mar-01-2017
55 Vertebral Technologies, Inc. II Feb-08-2017
56 Zimmer Biomet, Inc. II Jun-02-2020
57 Zimmer Biomet, Inc. II Jan-28-2020
58 Zimmer Biomet, Inc. II Dec-03-2019
59 Zimmer Biomet, Inc. II Nov-22-2019
60 Zimmer Biomet, Inc. II Nov-07-2019
61 Zimmer Biomet, Inc. II Jul-04-2019
62 Zimmer Biomet, Inc. II Jun-19-2019
63 Zimmer Biomet, Inc. II Jun-06-2019
64 Zimmer Biomet, Inc. II Nov-30-2018
65 Zimmer Biomet, Inc. II Aug-18-2018
66 Zimmer Biomet, Inc. II Aug-17-2018
67 Zimmer Biomet, Inc. II Apr-20-2018
68 Zimmer Biomet, Inc. II Mar-28-2018
69 Zimmer Biomet, Inc. II Mar-06-2018
70 Zimmer Biomet, Inc. II Feb-27-2018
71 Zimmer Biomet, Inc. II Feb-07-2018
72 Zimmer Biomet, Inc. II Feb-04-2018
73 Zimmer Biomet, Inc. II Apr-25-2017
74 Zimmer Biomet, Inc. II Oct-14-2016
75 Zimmer Gmbh II Aug-02-2016
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