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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device inoperable 570
Device operates differently than expected 213
Break 196
Unintended energization 129
Battery issue 110
Sticking 79
Failure to power-up 65
Overheating of device or device component 61
Noise, Audible 61
Fracture 59
Mechanical jam 57
Material fragmentation 55
Disassembly 48
Device remains activated 46
Failure to charge 40
Device disinfection or sterilization issue 40
Loose or intermittent connection 36
Temperature issue 32
Blockage within device or device component 31
Leak 30
Loss of power 27
Metal shedding debris 27
Slippage of device or device component 25
Self-activation or keying 24
Mechanical issue 23
Naturally worn 23
Defective item 22
Device stops intermittently 20
Component missing 20
Detachment of device component 17
Power source issue 16
Defective component 15
Vibration 15
Failure to shut off 14
No code available 11
Positioning Issue 10
Fail-safe mechanism issue 10
Material separation 10
Power Conditioning Issue 10
Premature discharge of battery 10
Connection issue 9
Charging issue 8
Material integrity issue 8
Melted 8
Air leak 7
Physical resistance 7
Detachment of device or device component 7
Other (for use when an appropriate device code cannot be identified) 6
Spark 6
Disconnection 6
Smoking 6
Difficult to remove 5
Burn of device or device component 5
Dull 5
No Information 5
Unintended movement 4
Output below specifications 4
No Known Device Problem 4
Failure to align 4
Device displays error message 4
Corrosion 4
Crack 4
Application interface becomes non-functional or program exits abnormally 4
Improper or incorrect procedure or method 4
Fluid leak 3
Degraded 3
Bent 3
Biocompatibility issue 3
Failure to disconnect 3
Difficult to open or close 3
Mechanics altered 3
Inadequate user interface 3
Device handling issue 3
Scratched material 3
No Pressure 2
Operating system becomes non-functional 2
Difficult or delayed activation 2
Cut in material 2
Loss of or failure to bond 2
Circuit Failure 2
Electrical issue 2
Continuous firing 2
Retraction problem 2
Device emits odor 2
Misconnection 2
Moisture damage 2
Fitting problem 2
Size incorrect for patient 2
Unstable 2
Stopcock valve, failure of 1
Device contamination with blood or blood product 1
Tear, rip or hole in device packaging 1
Poor quality image 1
Delivered as unsterile product 1
Unintended system motion 1
Failure to run on portable mode 1
Material rigid or stiff 1
Device Difficult to Setup or Prepare 1
Lens, disc 1
Migration of device or device component 1
Total Device Problems 2512

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 0 3 1 3 0 1 1 6 2
Class III 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Sep-08-2009
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Greatbatch Medical II Jun-01-2016
4 Linvatec Corp. dba ConMed Linvatec II Apr-04-2011
5 Linvatec Corp. dba ConMed Linvatec I Oct-01-2009
6 Medtronic Sofamor Danek USA Inc II Jan-12-2015
7 Smith & Nephew, Inc., Endoscopy Div. II Oct-22-2015
8 Stryker Instruments Div. of Stryker Corporation III May-07-2015
9 Stryker Instruments Div. of Stryker Corporation II Feb-09-2015
10 Stryker Instruments Div. of Stryker Corporation II Nov-05-2014
11 Stryker Instruments Div. of Stryker Corporation II Sep-13-2010
12 Stryker Instruments Div. of Stryker Corporation II Mar-30-2009
13 Synthes (USA) Products LLC II Jul-12-2016
14 Synthes USA (HQ), Inc. II Dec-02-2011
15 Synthes USA (HQ), Inc. II Oct-26-2009
16 Synthes USA HQ, Inc. II Dec-31-2013
17 Synthes, Inc. II Mar-23-2015
18 The Anspach Effort, Inc. II Apr-30-2015
19 W & H DentalWerk Buermoos GMBH II Jul-25-2011

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