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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2017 82 82
2018 104 104
2019 196 196
2020 354 354
2021 402 402

Device Problems MDRs with this Device Problem Events in those MDRs
Break 716 716
Material Deformation 175 175
Mechanical Jam 68 68
Material Twisted/Bent 31 31
Incorrect Measurement 25 25
Device-Device Incompatibility 24 24
Component Missing 24 24
Use of Device Problem 19 19
Fracture 19 19
Mechanical Problem 13 13
Detachment of Device or Device Component 10 10
Appropriate Term/Code Not Available 10 10
Material Integrity Problem 9 9
Bent 9 9
Device Operates Differently Than Expected 8 8
Material Discolored 6 6
Material Fragmentation 5 5
Sticking 5 5
Difficult to Remove 4 4
Particulates 3 3
Device Slipped 3 3
Crack 3 3
Device Markings/Labelling Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 3 3
Naturally Worn 2 2
Separation Failure 2 2
Defective Device 2 2
Fitting Problem 2 2
Entrapment of Device 2 2
Misassembled 2 2
Difficult To Position 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Unstable 1 1
Disassembly 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 448 448
No Consequences Or Impact To Patient 315 315
No Patient Involvement 282 282
No Known Impact Or Consequence To Patient 57 57
No Code Available 19 19
Insufficient Information 13 13
No Information 11 11
Foreign Body In Patient 5 5
Not Applicable 3 3
Injury 2 2
Bone Fracture(s) 1 1
Pneumothorax 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Jul-04-2019
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