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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extractor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWB
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 302 302
2021 322 322
2022 319 319
2023 350 350
2024 286 286
2025 105 105

Device Problems MDRs with this Device Problem Events in those MDRs
Break 770 770
Device-Device Incompatibility 365 365
Material Deformation 178 178
Material Twisted/Bent 161 161
Naturally Worn 134 134
Fracture 75 75
Mechanical Jam 59 59
Crack 53 53
Material Integrity Problem 30 30
No Apparent Adverse Event 19 19
Mechanical Problem 16 16
Entrapment of Device 12 12
Contamination /Decontamination Problem 12 12
Scratched Material 11 11
Detachment of Device or Device Component 9 9
Corroded 8 8
Appropriate Term/Code Not Available 8 8
Illegible Information 8 8
Physical Resistance/Sticking 7 7
Device Slipped 7 7
Difficult to Remove 6 6
Use of Device Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Difficult to Open or Close 6 6
Structural Problem 5 5
Defective Device 5 5
Unintended Movement 4 4
Material Fragmentation 3 3
Component Missing 3 3
Failure to Cut 3 3
Loose or Intermittent Connection 3 3
Device Damaged by Another Device 2 2
Mechanics Altered 2 2
Off-Label Use 2 2
Dull, Blunt 2 2
Degraded 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Difficult to Maintain 1 1
Device Handling Problem 1 1
Device Damaged Prior to Use 1 1
Activation Problem 1 1
Output Problem 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1246 1246
No Consequences Or Impact To Patient 216 216
Insufficient Information 188 188
No Code Available 52 52
Foreign Body In Patient 13 13
Not Applicable 9 9
No Patient Involvement 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Known Impact Or Consequence To Patient 7 7
Failure of Implant 6 6
Bone Fracture(s) 5 5
Pain 3 3
Unspecified Tissue Injury 3 3
Unspecified Infection 2 2
Muscle Weakness 2 2
Unspecified Nervous System Problem 2 2
Seroma 2 2
Injury 2 2
Numbness 2 2
Cerebrospinal Fluid Leakage 2 2
Rheumatoid Arthritis 1 1
Discomfort 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Innomed, Inc. II May-01-2024
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