TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	873	873
Physical Resistance/Sticking	52	52
Adverse Event Without Identified Device or Use Problem	50	50
Entrapment of Device	49	49
Difficult to Remove	48	48
Material Twisted/Bent	44	44
Fracture	38	38
Detachment of Device or Device Component	38	38
Material Fragmentation	32	32
Dull, Blunt	30	30
Corroded	19	19
Defective Device	19	19
Mechanical Jam	18	18
Appropriate Term/Code Not Available	17	17
Material Separation	16	16
Material Split, Cut or Torn	12	12
Mechanical Problem	11	11
Component Missing	11	11
Flaked	11	11
Fitting Problem	10	10
Material Deformation	10	10
Connection Problem	9	9
Device Damaged by Another Device	8	8
Failure to Disinfect	8	8
Activation, Positioning or Separation Problem	7	7
Naturally Worn	7	7
Failure to Cut	6	6
Crack	6	6
Use of Device Problem	6	6
Difficult to Open or Close	6	6
Patient Device Interaction Problem	6	6
Failure to Advance	6	6
Device Difficult to Maintain	5	5
Unintended Movement	5	5
Insufficient Information	5	5
Contamination /Decontamination Problem	5	5
Device Dislodged or Dislocated	4	4
Output Problem	4	4
Device-Device Incompatibility	4	4
Device Slipped	4	4
Inadequacy of Device Shape and/or Size	3	3
Difficult to Insert	3	3
Misfire	3	3
Incorrect Measurement	3	3
Device Damaged Prior to Use	3	3
Delivered as Unsterile Product	3	3
Separation Problem	3	3
Device Contamination with Chemical or Other Material	2	2
Product Quality Problem	2	2
Melted	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	693	693
Insufficient Information	266	266
Foreign Body In Patient	199	199
Device Embedded In Tissue or Plaque	83	83
No Known Impact Or Consequence To Patient	66	66
No Consequences Or Impact To Patient	41	41
No Patient Involvement	31	31
Failure of Implant	19	19
Injury	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Infection	9	9
Pain	9	9
Bone Fracture(s)	9	9
No Information	7	7
Unspecified Tissue Injury	6	6
Perforation	6	6
No Code Available	5	5
Low Blood Pressure/ Hypotension	4	4
Swelling/ Edema	4	4
Pericardial Effusion	4	4
Cardiac Tamponade	3	3
Post Operative Wound Infection	3	3
Tissue Damage	3	3
Purulent Discharge	2	2
Inflammation	2	2
Discomfort	2	2
Metal Related Pathology	2	2
Not Applicable	2	2
Laceration(s)	2	2
Joint Laxity	2	2
Heart Block	2	2
Internal Organ Perforation	2	2
Synovitis	1	1
Edema	1	1
Obstruction/Occlusion	1	1
Hematoma	1	1
Sepsis	1	1
Exposure to Body Fluids	1	1
Muscular Rigidity	1	1
Loss of Range of Motion	1	1
Cardiogenic Shock	1	1
Joint Dislocation	1	1
Increased Appetite	1	1
Subluxation	1	1
Arthralgia	1	1
Hip Fracture	1	1
Perforation of Vessels	1	1
Hypoxia	1	1
Ulcer	1	1
Wound Dehiscence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	II	Mar-27-2024
2	Arthrex, Inc.	II	Dec-08-2022
3	ENDO Pharmaceuticals Solutions, Inc.	II	Dec-30-2022
4	FlexDex Inc.	II	Jan-27-2022
5	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
6	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
8	Sklar Instruments	II	Jan-16-2025
9	Technicality Inc.	II	Apr-02-2024