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	1018	1019
Physical Resistance/Sticking	64	64
Material Twisted/Bent	55	55
Adverse Event Without Identified Device or Use Problem	53	53
Difficult to Remove	50	50
Entrapment of Device	49	49
Detachment of Device or Device Component	42	42
Fracture	39	39
Material Fragmentation	37	37
Dull, Blunt	35	35
Defective Device	23	23
Mechanical Jam	19	19
Appropriate Term/Code Not Available	19	19
Corroded	19	19
Material Separation	17	17
Material Split, Cut or Torn	15	16
Component Missing	12	12
Patient Device Interaction Problem	12	12
Flaked	11	11
Mechanical Problem	11	11
Device Damaged by Another Device	10	10
Fitting Problem	10	10
Material Deformation	10	10
Use of Device Problem	10	10
Connection Problem	9	9
Failure to Disinfect	8	8
Naturally Worn	7	7
Activation, Positioning or Separation Problem	7	8
Crack	6	6
Difficult to Open or Close	6	6
Failure to Cut	6	6
Unintended Movement	6	6
Device Dislodged or Dislocated	6	6
Failure to Advance	6	6
Positioning Failure	6	6
Output Problem	5	5
Device Difficult to Maintain	5	5
Insufficient Information	5	5
Contamination /Decontamination Problem	5	5
Device-Device Incompatibility	5	5
Device Slipped	4	4
Misfire	4	4
Melted	4	4
Difficult to Insert	3	3
Inadequacy of Device Shape and/or Size	3	3
Incorrect Measurement	3	3
Separation Problem	3	3
Delivered as Unsterile Product	3	3
Device Damaged Prior to Use	3	3
Product Quality Problem	2	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	814	818
Insufficient Information	307	308
Foreign Body In Patient	249	249
Device Embedded In Tissue or Plaque	84	84
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
Unspecified Infection	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Pain	11	11
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
Tissue Damage	3	3
Cardiac Tamponade	3	3
Post Operative Wound Infection	3	3
Laceration(s)	3	3
Internal Organ Perforation	2	2
Heart Block	2	2
Hemorrhage/Bleeding	2	2
Joint Laxity	2	2
Perforation of Vessels	2	2
Discomfort	2	2
Not Applicable	2	2
Metal Related Pathology	2	2
Purulent Discharge	2	2
Inflammation	2	2
Joint Dislocation	1	1
Arthralgia	1	1
Exposure to Body Fluids	1	1
Muscular Rigidity	1	1
Loss of Range of Motion	1	1
Cardiogenic Shock	1	1
Hip Fracture	1	1
Increased Appetite	1	1
Subluxation	1	1
Obstruction/Occlusion	1	1
Edema	1	1
Wound Dehiscence	1	1
Non-union Bone Fracture	1	1
Synovitis	1	1
Hypoxia	1	1
Ulcer	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