Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bit, drill
Product CodeHTW
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 409 409
2015 398 398
2016 593 593
2017 1129 1129
2018 1240 1240
2019 1211 1211
2020 1245 1245
2021 1569 1569
2022 1519 1519
2023 1771 1771
2024 353 353

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6566 6566
Failure to Cut 986 986
Fracture 760 760
Entrapment of Device 707 707
Material Deformation 597 597
Device-Device Incompatibility 583 583
Material Twisted/Bent 427 427
Dull, Blunt 350 350
Material Fragmentation 308 308
Naturally Worn 260 260
Bent 240 240
Device Operates Differently Than Expected 136 136
Mechanical Jam 114 114
Appropriate Term/Code Not Available 90 90
Detachment Of Device Component 89 89
Material Integrity Problem 82 82
Corroded 67 67
Detachment of Device or Device Component 65 65
Adverse Event Without Identified Device or Use Problem 64 64
Contamination /Decontamination Problem 63 63
Difficult to Remove 55 55
Failure to Align 52 52
Physical Resistance/Sticking 42 42
Insufficient Information 42 42
Illegible Information 37 37
Component Missing 37 37
No Apparent Adverse Event 36 36
Crack 35 35
Use of Device Problem 33 33
Mechanical Problem 30 30
Degraded 27 27
Improper or Incorrect Procedure or Method 27 27
Device Markings/Labelling Problem 25 25
Packaging Problem 22 22
Fitting Problem 21 21
Scratched Material 20 20
Delivered as Unsterile Product 19 19
Material Separation 17 17
Overheating of Device 16 16
Device Contaminated During Manufacture or Shipping 16 16
Separation Failure 16 16
Unintended Movement 15 15
Component Falling 14 14
Sticking 13 13
Device Contamination with Chemical or Other Material 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Difficult to Insert 12 12
Device Inoperable 11 11
Metal Shedding Debris 11 11
Incorrect Measurement 11 11
Positioning Problem 10 10
Device Handling Problem 10 10
Structural Problem 10 10
Defective Device 8 8
Tear, Rip or Hole in Device Packaging 8 8
Noise, Audible 8 8
Smoking 7 7
Difficult to Advance 7 7
Connection Problem 6 6
Device Or Device Fragments Location Unknown 6 6
Patient Device Interaction Problem 6 6
Temperature Problem 6 6
Loss of or Failure to Bond 6 6
Flaked 5 5
Loose or Intermittent Connection 5 5
Product Quality Problem 5 5
Unraveled Material 5 5
Nonstandard Device 5 5
Device Slipped 5 5
Mechanics Altered 5 5
Material Split, Cut or Torn 4 4
Residue After Decontamination 4 4
Device Issue 4 4
Failure to Advance 4 4
Device Dislodged or Dislocated 4 4
Difficult To Position 4 4
Unknown (for use when the device problem is not known) 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Erosion 3 3
Partial Blockage 3 3
Activation, Positioning or Separation Problem 3 3
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Difficult to Maintain 3 3
Device Packaging Compromised 3 3
Inaccurate Information 3 3
Device Fell 3 3
Unclear Information 2 2
Material Distortion 2 2
Measurement System Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Expiration Date Error 2 2
Failure to Disconnect 2 2
Thermal Decomposition of Device 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Disassembly 2 2
Material Disintegration 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4371 4371
No Consequences Or Impact To Patient 2413 2413
No Known Impact Or Consequence To Patient 1305 1305
Foreign Body In Patient 1098 1098
Device Embedded In Tissue or Plaque 701 701
No Information 586 586
No Code Available 462 462
Insufficient Information 459 459
No Patient Involvement 300 300
Not Applicable 166 166
Injury 73 73
Sedation 36 36
Bone Fracture(s) 29 29
Failure of Implant 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Pain 16 16
Burn(s) 15 15
Unspecified Tissue Injury 13 13
Unspecified Infection 10 10
Hemorrhage/Bleeding 10 10
Tissue Damage 10 10
Patient Problem/Medical Problem 8 8
Blood Loss 5 5
Perforation 5 5
Pneumothorax 4 4
Hematoma 4 4
Laceration(s) 4 4
Nerve Damage 4 4
Discomfort 4 4
Non-union Bone Fracture 3 3
Impaired Healing 3 3
Death 3 3
Paralysis 3 3
Perforation of Vessels 3 3
Rupture 2 2
Swelling 2 2
Fall 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Necrosis 1 1
Infiltration into Tissue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Debris, Bone Shedding 1 1
Eye Injury 1 1
Synovitis 1 1
Loss of Range of Motion 1 1
Scarring 1 1
Sepsis 1 1
Spinal Column Injury 1 1
Distress 1 1
Chills 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
Deformity/ Disfigurement 1 1
Foreign body, removal of 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Thromboembolism 1 1
Superficial (First Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Vascular Dissection 1 1
Ischemia Stroke 1 1
Limb Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag III Dec-22-2019
2 Arthrex, Inc. II Mar-26-2021
3 Biomet, Inc. II Dec-17-2020
4 Biomet, Inc. II May-26-2016
5 Cayenne Medical Inc. II Jul-28-2018
6 Exactech, Inc. II Sep-11-2012
7 Flower Orthopedics Corporation II Oct-14-2021
8 Intelifuse Inc II Mar-05-2009
9 Interventional Spine Inc II Jan-11-2012
10 Linvatec Corp. dba ConMed Linvatec II Nov-19-2012
11 MicroAire Surgical Instruments, LLC II Jan-26-2018
12 NEOSTEO II Aug-09-2021
13 Orthohelix Surgical Designs Inc II Mar-22-2013
14 Orthohelix Surgical Designs Inc II Apr-22-2010
15 Paragon 28, Inc. II Sep-17-2021
16 Smith & Nephew Inc II Jun-06-2012
17 Sterilmed Inc II Jan-13-2009
18 Stryker Howmedica Osteonics Corp. II May-01-2013
19 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
20 Synthes (USA) Products LLC II May-23-2016
21 Synthes USA (HQ), Inc. II Jan-11-2012
22 Synthes USA HQ, Inc. II Nov-27-2013
23 Synthes, Inc. II Jun-04-2015
24 The Anspach Effort, Inc. II Jan-11-2014
25 The Anspach Effort, Inc. II Jul-25-2012
26 Tornier, Inc II May-09-2018
27 Trilliant Surgical Ltd. II Aug-24-2015
28 Trilliant Surgical, LLC II May-05-2020
29 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-06-2024
30 Zimmer GmbH II May-23-2019
31 Zimmer, Inc. II May-24-2013
-
-