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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauge, depth
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2019 196 196
2020 354 354
2021 403 403
2022 316 316
2023 376 376
2024 252 252

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1089 1089
Material Deformation 437 437
Mechanical Jam 113 113
Device-Device Incompatibility 74 74
Incorrect Measurement 49 49
Use of Device Problem 36 36
Fracture 33 33
Material Twisted/Bent 33 33
Detachment of Device or Device Component 24 24
Mechanical Problem 22 22
Naturally Worn 21 21
Material Integrity Problem 20 20
Illegible Information 17 17
Component Missing 11 11
Device Slipped 9 9
Appropriate Term/Code Not Available 8 8
Entrapment of Device 7 7
Crack 7 7
No Apparent Adverse Event 7 7
Material Discolored 7 7
Defective Device 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Cut 4 4
Degraded 4 4
Unintended Movement 2 2
Separation Failure 2 2
Material Fragmentation 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Contamination /Decontamination Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Damaged by Another Device 1 1
Difficult to Remove 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Misassembled 1 1
Device Fell 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Misassembled 1 1
Device Markings/Labelling Problem 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1
Fitting Problem 1 1
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1
Disconnection 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1334 1334
No Consequences Or Impact To Patient 269 269
No Patient Involvement 208 208
Insufficient Information 66 66
No Code Available 11 11
No Known Impact Or Consequence To Patient 10 10
Foreign Body In Patient 10 10
Not Applicable 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Failure of Implant 1 1
Bone Fracture(s) 1 1
Injury 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 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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