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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines & accessories (compound, powered)
Regulation Description Powered compound cranial drills, burrs, trephines, and their accessories.
Product CodeHBF
Regulation Number 882.4305
Device Class 2


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 52
Failure to auto stop 50
Use of Device Issue 17
Dull 15
No Known Device Problem 13
No code available 4
Fail-safe mechanism issue 3
Foreign material present in device 3
Disconnection 3
Break 2
Device Issue 2
Plunge 2
Device operates differently than expected 2
No Information 2
Loss of power 1
Device remains activated 1
Device, or device fragments remain in patient 1
Failure to sense 1
Malfunction 1
Application interface becomes non-functional or program exits abnormally 1
Design/structure problem 1
Material discolored 1
Flaked 1
Difficult to insert 1
Unsealed device packaging 1
Total Device Problems 181

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Jan-11-2012

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