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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
Failure to auto stop 98
Other (for use when an appropriate device code cannot be identified) 52
Dull 25
No Known Device Problem 23
Use of Device Issue 20
Device remains activated 10
No Information 5
No code available 4
Foreign material present in device 4
Peeled 4
Plunge 4
Metal shedding debris 3
Break 3
Disconnection 3
Fail-safe mechanism issue 3
Device operates differently than expected 2
Device Issue 2
Loss of power 1
Device, or device fragments remain in patient 1
Failure to sense 1
Flaked 1
Difficult to insert 1
Unsealed device packaging 1
Application interface becomes non-functional or program exits abnormally 1
Design/structure problem 1
Material discolored 1
Malfunction 1
Total Device Problems 275

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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