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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device punch, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRY
Regulation Number 878.4800
Device Class 1

Device Problems
Break 170
Material Deformation 41
Device-Device Incompatibility 35
Appropriate Term/Code Not Available 32
Naturally Worn 26
Material Twisted / Bent 23
Loose or Intermittent Connection 11
Connection Problem 9
Material Integrity Problem 9
Crack 9
Difficult to Remove 7
Material Fragmentation 6
Bent 6
Dull, Blunt 4
Fracture 4
Physical Resistance / Sticking 3
Fitting Problem 3
Device Operates Differently Than Expected 3
Device Contamination with Chemical or Other Material 3
Illegible Information 3
Device Issue 2
Disassembly 2
Device Dislodged or Dislocated 2
Insufficient Information 2
Scratched Material 2
Detachment of Device or device Component 2
Contamination During Use 1
Difficult to Insert 1
Device Damaged Prior to Use 1
Adverse Event Without Identified Device or Use Problem 1
Component Missing 1
Nonstandard device 1
Activation, Positioning or Separation Problem 1
Contamination / decontamination Problem 1
Component Misassembled 1
Positioning Problem 1
Failure To Adhere Or Bond 1
Delivered as Unsterile Product 1
Defective Device 1
Device Or Device Fragments Location Unknown 1
Incorrect Measurement 1
Unintended Movement 1
Total Device Problems 435

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Mar-01-2018
2 DePuy Orthopaedics, Inc. II Feb-09-2016

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