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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 34
Use of Device Issue 13
Dull 11
No Known Device Problem 9
Disconnection 3
Fail-safe mechanism issue 3
No code available 3
Break 2
Device Issue 2
Plunge 2
Device operates differently than expected 2
Malfunction 1
No Information 1
Foreign material present in device 1
Device, or device fragments remain in patient 1
Failure to sense 1
Application interface becomes non-functional or program exits abnormally 1
Design/structure problem 1
Flaked 1
Difficult to insert 1
Total Device Problems 145

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