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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
Device-Device Incompatibility 363
Break 253
Appropriate Term/Code Not Available 166
Scratched Material 113
Loose or Intermittent Connection 108
Naturally Worn 87
Connection Problem 83
Unintended Movement 70
Material Deformation 64
Material Twisted / Bent 56
Fracture 47
Component Missing 34
Physical Resistance / Sticking 21
Fitting Problem 21
Bent 20
Adverse Event Without Identified Device or Use Problem 20
Device Slipped 19
Dull, Blunt 18
Crack 18
Insufficient Information 16
Mechanical Jam 15
Inadequacy of Device Shape and/or Size 14
Mechanical Problem 14
Difficult to Remove 12
Entrapment of Device 7
Device Markings / Labelling Problem 6
Difficult to Insert 5
Structural Problem 5
Positioning Problem 5
Misconnection 4
Device Contamination with Chemical or Other Material 4
Device Issue 4
Contamination / decontamination Problem 4
Incomplete or Inadequate Connection 4
Defective Device 3
Device Damaged by Another Device 2
Deformation Due to Compressive Stress 2
Blocked Connection 2
Material Integrity Problem 2
Disassembly 2
Failure to Advance 2
Difficult to Open or Close 2
Detachment of Device or device Component 2
Device Damaged Prior to Use 2
Separation Problem 2
Solder Joint Fracture 1
Manufacturing, Packaging or Shipping Problem 1
Migration 1
Difficult To Position 1
Positioning Failure 1
Material Discolored 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Material Disintegration 1
Failure to Clean Adequately 1
Compatibility Problem 1
Use of Device Problem 1
Failure to Disconnect 1
Loss of or Failure to Bond 1
Total Device Problems 1736

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

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