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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device awl
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWJ
Regulation Number 888.4540
Device Class 1

Device Problems
Break 23
Material fragmentation 6
Unknown (for use when the device problem is not known) 2
Fracture 2
Device operates differently than expected 2
Material twisted 1
No Information 1
Bent 1
Detachment of device component 1
Corrosion 1
Failure to align 1
Device, or device fragments remain in patient 1
Improper or incorrect procedure or method 1
Total Device Problems 43

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