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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, pneumatic powered & accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHSZ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2017 24 24
2018 13 13
2019 5 5
2020 13 13
2021 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 39 39
Material Rupture 13 13
Air Leak 9 9
Entrapment of Device 6 6
Failure to Cut 3 3
Material Deformation 2 2
Device Inoperable 2 2
Noise, Audible 2 2
Output below Specifications 2 2
Power Problem 1 1
Unintended Movement 1 1
Vibration 1 1
Defective Component 1 1
Dull, Blunt 1 1
Fluid Leak 1 1
Fracture 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Overheating of Device 1 1
Mechanical Jam 1 1
Detachment Of Device Component 1 1
Disassembly 1 1
Contamination /Decontamination Problem 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 24 24
No Known Impact Or Consequence To Patient 19 19
Foreign Body In Patient 6 6
No Code Available 3 3
No Patient Involvement 3 3
Burn(s) 1 1
Laceration(s) 1 1
Insufficient Information 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II May-04-2017
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