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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, surgical, instrument
Product CodeFSM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 104 104
2019 168 168
2020 148 148
2021 153 153
2022 200 200
2023 143 143

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 308 308
Break 237 237
Contamination /Decontamination Problem 100 100
Naturally Worn 73 73
Crack 71 71
Material Twisted/Bent 53 53
Flaked 41 41
Fracture 31 31
Adverse Event Without Identified Device or Use Problem 29 29
Incorrect Measurement 20 20
Material Discolored 19 19
Corroded 19 19
Material Integrity Problem 16 16
Appropriate Term/Code Not Available 15 15
Component Missing 13 13
Material Fragmentation 11 11
Scratched Material 9 9
Patient-Device Incompatibility 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Material Deformation 7 7
Delamination 7 7
Detachment of Device or Device Component 6 6
Device-Device Incompatibility 6 6
Mechanical Problem 6 6
Unsealed Device Packaging 6 6
No Apparent Adverse Event 6 6
Residue After Decontamination 5 5
Dull, Blunt 5 5
Device Damaged Prior to Use 4 4
Defective Component 4 4
Structural Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Degraded 4 4
Device Reprocessing Problem 3 3
Loose or Intermittent Connection 3 3
Use of Device Problem 3 3
Product Quality Problem 3 3
Difficult to Remove 3 3
Connection Problem 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Illegible Information 3 3
Premature Separation 2 2
Material Split, Cut or Torn 2 2
Sharp Edges 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Sparking 2 2
Microbial Contamination of Device 2 2
Overheating of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Entrapment of Device 2 2
Coagulation in Device or Device Ingredient 2 2
Loss of or Failure to Bond 2 2
Hole In Material 2 2
Inadequate Instructions for Healthcare Professional 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Fluid/Blood Leak 1 1
Positioning Failure 1 1
Contamination 1 1
Particulates 1 1
Melted 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Sticking 1 1
Device Inoperable 1 1
Metal Shedding Debris 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Incorrect Or Inadequate Test Results 1 1
Device Issue 1 1
Failure to Align 1 1
Biocompatibility 1 1
Component or Accessory Incompatibility 1 1
Mechanical Jam 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Output Problem 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 473 473
No Consequences Or Impact To Patient 297 297
No Known Impact Or Consequence To Patient 38 38
Insufficient Information 26 26
No Patient Involvement 24 24
No Code Available 22 22
Not Applicable 13 13
Pain 7 7
Laceration(s) 6 6
Failure of Implant 6 6
No Information 5 5
Foreign Body In Patient 5 5
Device Embedded In Tissue or Plaque 3 3
Bone Fracture(s) 3 3
Unspecified Infection 2 2
Injury 2 2
Metal Related Pathology 2 2
Joint Laxity 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Inadequate Osseointegration 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Retinal Injury 1 1
Hematoma 1 1
Hemolysis 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Burn(s) 1 1
Cataract 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Apr-25-2023
2 Howmedica Osteonics Corp. II Jan-06-2022
3 Stradis Healthcare II Jan-11-2023
4 Synthes (USA) Products LLC II Jun-15-2018
5 Zimmer Biomet, Inc. II Jul-12-2019
6 Zimmer Biomet, Inc. II Jan-14-2019
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