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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
2019 168 168
2020 148 148
2021 153 153
2022 200 200
2023 170 170
2024 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 371 371
Break 231 231
Contamination /Decontamination Problem 133 133
Naturally Worn 74 74
Crack 72 72
Material Twisted/Bent 53 53
Flaked 41 41
Fracture 36 36
Incorrect Measurement 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Material Discolored 18 18
Corroded 18 18
Material Integrity Problem 17 17
Component Missing 13 13
Material Fragmentation 11 11
Scratched Material 10 10
No Apparent Adverse Event 8 8
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 7 7
Material Deformation 7 7
Device-Device Incompatibility 6 6
Mechanical Problem 6 6
Unsealed Device Packaging 5 5
Dull, Blunt 5 5
Illegible Information 5 5
Structural Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Product Quality Problem 4 4
Degraded 4 4
Loose or Intermittent Connection 3 3
Use of Device Problem 3 3
Connection Problem 3 3
Device Displays Incorrect Message 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Premature Separation 2 2
Sparking 2 2
Residue After Decontamination 2 2
Overheating of Device 2 2
Defective Device 2 2
Packaging Problem 2 2
Defective Component 2 2
Microbial Contamination of Device 2 2
Difficult to Remove 2 2
Entrapment of Device 2 2
Loss of or Failure to Bond 2 2
Device Reprocessing Problem 2 2
Contamination 2 2
Positioning Failure 1 1
Failure to Discharge 1 1
Inadequate Instructions for Healthcare Professional 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Device Damaged Prior to Use 1 1
Particulates 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Melted 1 1
Moisture Damage 1 1
Output Problem 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Failure to Align 1 1
Separation Failure 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 594 594
No Consequences Or Impact To Patient 232 232
Insufficient Information 42 42
No Known Impact Or Consequence To Patient 20 20
No Code Available 19 19
No Patient Involvement 17 17
Not Applicable 10 10
Pain 7 7
Failure of Implant 6 6
Bone Fracture(s) 3 3
Laceration(s) 3 3
Injury 2 2
Unspecified Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Foreign Body In Patient 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
No Information 1 1
Hematoma 1 1
Hemorrhage/Bleeding 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
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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Apr-25-2023
2 Howmedica Osteonics Corp. II Jan-06-2022
3 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
4 Stradis Healthcare II Jan-11-2023
5 Zimmer Biomet, Inc. II Jul-12-2019
6 Zimmer Biomet, Inc. II Jan-14-2019
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