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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

Device Problems
Break 197
Appropriate Term/Code Not Available 148
Device-Device Incompatibility 127
Loose or Intermittent Connection 87
Scratched Material 75
Naturally Worn 71
Connection Problem 65
Material Deformation 42
Component Missing 33
Fracture 27
Bent 20
Fitting Problem 20
Insufficient Information 17
Material Twisted / Bent 16
Crack 13
Mechanical Problem 13
Physical Resistance / Sticking 11
Inadequacy of Device Shape and/or Size 8
Mechanical Jam 7
Unintended Movement 6
Difficult to Remove 6
Adverse Event Without Identified Device or Use Problem 5
Difficult to Insert 5
Positioning Problem 4
Device Slipped 4
Incomplete or Inadequate Connection 4
Device Issue 4
Misconnection 4
Dull, Blunt 3
Entrapment of Device 3
Device Damaged Prior to Use 2
Defective Device 2
Blocked Connection 2
Separation Problem 2
Deformation Due to Compressive Stress 2
Disassembly 2
Loss of or Failure to Bond 1
Difficult to Open or Close 1
Solder Joint Fracture 1
Failure to Advance 1
Compatibility Problem 1
Material Integrity Problem 1
Material Disintegration 1
Detachment of Device or device Component 1
Difficult To Position 1
Failure to Disconnect 1
Manufacturing, Packaging or Shipping Problem 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Failure to Clean Adequately 1
Total Device Problems 1070

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II May-09-2017

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