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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 39 39
2021 35 35
2022 41 41
2023 47 47
2024 36 36
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 128 128
Fracture 40 40
Material Twisted/Bent 14 14
Material Deformation 12 12
Entrapment of Device 9 9
Material Fragmentation 5 5
Device-Device Incompatibility 5 5
Material Separation 3 3
Material Integrity Problem 3 3
Material Split, Cut or Torn 3 3
Contamination /Decontamination Problem 3 3
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Illegible Information 2 2
Detachment of Device or Device Component 2 2
Device Slipped 1 1
Component Missing 1 1
Material Discolored 1 1
Mechanical Jam 1 1
Difficult to Insert 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
Foreign Body In Patient 19 19
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 9 9
Device Embedded In Tissue or Plaque 6 6
No Patient Involvement 4 4
Injury 2 2
Perforation 1 1
Spinal Column Injury 1 1
No Code Available 1 1
Failure of Implant 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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