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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
Product CodeHSZ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 13 13
2021 27 27
2022 35 35
2023 39 39
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 75 75
Failure to Cut 24 24
Entrapment of Device 17 17
Device-Device Incompatibility 5 5
Overheating of Device 5 5
Excessive Heating 3 3
Unintended Movement 2 2
Material Rupture 2 2
Material Deformation 2 2
Output below Specifications 2 2
Leak/Splash 1 1
Expulsion 1 1
Physical Resistance/Sticking 1 1
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Unintended Ejection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Appropriate Term/Code Not Available 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 89
Foreign Body In Patient 16 16
No Consequences Or Impact To Patient 7 7
Insufficient Information 6 6
No Known Impact Or Consequence To Patient 4 4
Laceration(s) 2 2
Hearing Impairment 1 1
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
No Code Available 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Pain 1 1
Tinnitus 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
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