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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 239 239

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 466 466
Break 237 237
Contamination /Decontamination Problem 161 161
Crack 100 100
Naturally Worn 90 90
Material Twisted/Bent 53 53
Flaked 41 41
Material Discolored 40 40
Fracture 40 40
Incorrect Measurement 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Corroded 19 19
No Apparent Adverse Event 18 18
Material Integrity Problem 17 17
Scratched Material 14 14
Component Missing 14 14
Material Fragmentation 11 11
Unsealed Device Packaging 8 8
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 7 7
Illegible Information 7 7
Material Deformation 7 7
Mechanical Problem 6 6
Device-Device Incompatibility 6 6
Dull, Blunt 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Degraded 4 4
Product Quality Problem 4 4
Use of Device Problem 4 4
Structural Problem 4 4
Connection Problem 3 3
Appropriate Term/Code Not Available 3 3
Entrapment of Device 3 3
Loose or Intermittent Connection 3 3
Device Displays Incorrect Message 3 3
Premature Separation 2 2
Overheating of Device 2 2
Device Reprocessing Problem 2 2
Residue After Decontamination 2 2
Loss of or Failure to Bond 2 2
Packaging Problem 2 2
Microbial Contamination of Device 2 2
Difficult to Remove 2 2
Contamination 2 2
Defective Device 2 2
Defective Component 2 2
Material Split, Cut or Torn 2 2
Sparking 2 2
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 706 706
No Consequences Or Impact To Patient 232 232
Insufficient Information 71 71
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
Foreign Body In Patient 4 4
Bone Fracture(s) 3 3
Laceration(s) 3 3
Unspecified Infection 2 2
Metal Related Pathology 2 2
Injury 2 2
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Wound Dehiscence 1 1
Death 1 1
Joint Dislocation 1 1
Inadequate Osseointegration 1 1
Cataract 1 1
No Information 1 1
Hematoma 1 1
Blood Loss 1 1
Retinal Injury 1 1
Post Operative Wound Infection 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Bradycardia 1 1
Non-union Bone Fracture 1 1
Joint Laxity 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 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 II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 Stradis Healthcare II Jan-11-2023
6 Zimmer Biomet, Inc. II Jul-12-2019
7 Zimmer Biomet, Inc. II Jan-14-2019
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