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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device passer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2016 28 28
2017 39 39
2018 64 64
2019 55 55
2020 170 170
2021 132 132

Device Problems MDRs with this Device Problem Events in those MDRs
Break 232 232
Material Separation 53 53
Mechanical Jam 32 32
Detachment of Device or Device Component 20 20
Failure to Advance 18 18
Mechanical Problem 17 17
Device Operates Differently Than Expected 13 13
Detachment Of Device Component 12 12
Material Integrity Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Material Fragmentation 9 9
Physical Resistance/Sticking 8 8
Fracture 8 8
Device Dislodged or Dislocated 5 5
Insufficient Information 5 5
Misassembled 5 5
Bent 5 5
Device Damaged Prior to Use 5 5
Positioning Failure 4 4
Device Fell 4 4
Ejection Problem 4 4
Firing Problem 4 4
Material Deformation 4 4
No Apparent Adverse Event 3 3
Material Split, Cut or Torn 3 3
Device-Device Incompatibility 3 3
Difficult to Open or Close 3 3
Failure to Fire 3 3
Activation, Positioning or SeparationProblem 3 3
Entrapment of Device 3 3
Delivered as Unsterile Product 3 3
Unsealed Device Packaging 2 2
Separation Failure 2 2
Component Falling 2 2
Nonstandard Device 2 2
Device Or Device Fragments Location Unknown 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contamination with Chemical or Other Material 2 2
Separation Problem 2 2
Device Packaging Compromised 2 2
Material Twisted/Bent 1 1
Output Problem 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Device Operational Issue 1 1
Device Disinfection Or Sterilization Issue 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Grounding Malfunction 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Difficult to Fold, Unfold or Collapse 1 1
Loss of or Failure to Bond 1 1
Defective Device 1 1
Expiration Date Error 1 1
Misfire 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Solder Joint Fracture 1 1
Cut In Material 1 1
Failure to Align 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 220 220
No Clinical Signs, Symptoms or Conditions 156 156
No Consequences Or Impact To Patient 45 45
No Information 25 25
Foreign Body In Patient 17 17
No Patient Involvement 14 14
Device Embedded In Tissue or Plaque 13 13
Injury 5 5
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypersensitivity/Allergic reaction 2 2
Pain 2 2
Tissue Damage 2 2
No Code Available 2 2
Tingling 1 1
Scar Tissue 1 1
Chills 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
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