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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
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 71 71
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
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
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2
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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