• 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
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTW
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 398 398
2016 589 589
2017 1129 1129
2018 1241 1241
2019 1212 1212
2020 769 769

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3288 3288
Fracture 365 365
Material Twisted/Bent 342 342
Dull, Blunt 326 326
Material Fragmentation 268 268
Bent 233 233
Entrapment of Device 163 163
Device-Device Incompatibility 151 151
Tip 133 133
Failure to Cut 119 119
Device Operates Differently Than Expected 102 102
Material Deformation 83 83
Detachment Of Device Component 75 75
Appropriate Term/Code Not Available 66 66
Naturally Worn 49 49
Detachment of Device or Device Component 43 43
Mechanical Jam 40 40
Corroded 40 40
Difficult to Remove 38 38
Failure to Align 36 36
Insufficient Information 35 35
Component Missing 30 30
Adverse Event Without Identified Device or Use Problem 30 30
Physical Resistance/Sticking 26 26
Use of Device Problem 24 24
Crack 22 22
Device Markings/Labelling Problem 19 19
Mechanical Problem 18 18
Delivered as Unsterile Product 17 17
Packaging Problem 16 16
Improper or Incorrect Procedure or Method 15 15
Pin 13 13
Separation Failure 13 13
Screw 13 13
Fitting Problem 12 12
Device Contamination with Chemical or Other Material 12 12
Unintended Movement 12 12
Material Integrity Problem 12 12
Component Falling 11 11
Incorrect Measurement 11 11
Metal Shedding Debris 10 10
Sticking 9 9
Contamination /Decontamination Problem 9 9
Device Inoperable 8 8
Defective Device 8 8
Illegible Information 8 8
Material Separation 7 7
Device Contaminated During Manufacture or Shipping 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Difficult to Insert 6 6
Loss of or Failure to Bond 6 6
Temperature Problem 6 6
Device Handling Problem 6 6
Noise, Audible 5 5
Loose or Intermittent Connection 5 5
Connection Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device Subassembly 5 5
Scratched Material 5 5
Mechanics Altered 4 4
Residue After Decontamination 4 4
Device Or Device Fragments Location Unknown 4 4
Device Issue 4 4
Degraded 4 4
Overheating of Device 4 4
Smoking 3 3
Nonstandard Device 3 3
Patient-Device Incompatibility 3 3
Device Packaging Compromised 3 3
Thread 3 3
Device Difficult to Maintain 3 3
Device Fell 3 3
Unraveled Material 3 3
Product Quality Problem 3 3
Shaft 3 3
Material Erosion 3 3
Flaked 3 3
Partial Blockage 2 2
Thermal Decomposition of Device 2 2
Unstable 2 2
Difficult or Delayed Positioning 2 2
Failure to Disconnect 2 2
Difficult to Advance 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Device Operational Issue 2 2
Deformation Due to Compressive Stress 2 2
Device Emits Odor 2 2
Unknown (for use when the device problem is not known) 1 1
Incomplete or Missing Packaging 1 1
Unsealed Device Packaging 1 1
Difficult To Position 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Shelf Life Exceeded 1 1
Device Slipped 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2165 2165
No Known Impact Or Consequence To Patient 1066 1066
No Information 558 558
Device Embedded In Tissue or Plaque 509 509
Foreign Body In Patient 502 502
No Code Available 354 354
No Patient Involvement 268 268
Not Applicable 161 161
Injury 54 54
Sedation 28 28
Bone Fracture(s) 13 13
Pain 11 11
Burn(s) 10 10
Tissue Damage 8 8
Patient Problem/Medical Problem 8 8
Failure of Implant 6 6
Hematoma 3 3
Blood Loss 3 3
Discomfort 3 3
Unspecified Infection 3 3
Laceration(s) 3 3
Paralysis 3 3
Hemorrhage/Bleeding 2 2
Swelling 2 2
Fall 2 2
Infiltration into Tissue 1 1
Perforation 1 1
Loss of Range of Motion 1 1
Spinal Column Injury 1 1
Hip Fracture 1 1
Foreign body, removal of 1 1
Death 1 1
Debris, Bone Shedding 1 1
Eye Injury 1 1
Pneumothorax 1 1
Scarring 1 1
Synovitis 1 1
Nerve Damage 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Reaction 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag III Dec-22-2019
2 Biomet, Inc. II May-26-2016
3 Cayenne Medical Inc. II Jul-28-2018
4 MicroAire Surgical Instruments, LLC II Jan-26-2018
5 Synthes (USA) Products LLC II May-23-2016
6 Synthes, Inc. II Jun-04-2015
7 Tornier, Inc II May-09-2018
8 Trilliant Surgical Ltd. II Aug-24-2015
9 Trilliant Surgical, LLC II May-05-2020
10 Zimmer GmbH II May-23-2019
-
-