TPLC - Total Product Life Cycle

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Device	tray, surgical, instrument
Regulation Description	Manual surgical instrument for general use.
Product Code	FSM
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	816	817
Contamination /Decontamination Problem	170	170
Break	154	155
Crack	144	144
Naturally Worn	72	72
No Apparent Adverse Event	53	53
Flaked	41	41
Fracture	40	40
Material Discolored	34	34
Material Deformation	23	23
Material Twisted/Bent	21	21
Material Integrity Problem	20	20
Unsealed Device Packaging	17	17
Scratched Material	16	16
Corroded	14	14
Illegible Information	11	11
Component Missing	11	11
Detachment of Device or Device Component	9	9
Incorrect Measurement	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Appropriate Term/Code Not Available	5	5
Melted	4	4
Residue After Decontamination	4	4
Structural Problem	4	4
Use of Device Problem	4	4
Material Fragmentation	4	4
Degraded	4	4
Mechanical Problem	4	4
Device-Device Incompatibility	4	4
Defective Component	3	3
Product Quality Problem	3	8
Output Problem	3	3
Microbial Contamination of Device	2	2
Premature Separation	2	2
Insufficient Information	2	2
Sharp Edges	2	2
Packaging Problem	2	2
Device Damaged Prior to Use	2	2
Entrapment of Device	2	2
Device Contaminated During Manufacture or Shipping	2	2
Connection Problem	2	2
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Deformation Due to Compressive Stress	1	1
Overheating of Device	1	1
Failure to Discharge	1	1
Inaccurate Information	1	1
Fluid/Blood Leak	1	1
Biocompatibility	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1205	1206
Insufficient Information	90	95
Laceration(s)	6	6
Failure of Implant	3	3
Foreign Body In Patient	3	3
Metal Related Pathology	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Joint Dislocation	1	1
Inadequate Osseointegration	1	1
Bone Fracture(s)	1	1
Post Operative Wound Infection	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Thrombosis/Thrombus	1	1
Exposure to Body Fluids	1	1
Loss of Range of Motion	1	1
Discomfort	1	1
Pain	1	1
Joint Laxity	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Apr-25-2023
2	Encore Medical, LP	II	Sep-10-2025
3	Howmedica Osteonics Corp.	II	Jan-06-2022
4	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
5	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
6	Medical Action Industries, Inc. 306	II	Sep-12-2024
7	Stradis Healthcare	II	Jan-11-2023