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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mallet
Regulation Description Manual surgical instrument for general use.
Product CodeHXL
Regulation Number 878.4800
Device Class 1

Device Problems
Break 1
Component falling 1
Fracture 1
Device, or device fragments remain in patient 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Semiautomatic code, failure to override 1
Dislodged or dislocated 1
Total Device Problems 8

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