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	707	707
Physical Resistance/Sticking	69	69
Material Twisted/Bent	53	53
Dull, Blunt	48	48
Adverse Event Without Identified Device or Use Problem	31	31
Fracture	30	33
Material Fragmentation	29	29
Detachment of Device or Device Component	28	28
Defective Device	22	22
Use of Device Problem	21	21
Corroded	18	18
Patient Device Interaction Problem	14	14
Device Damaged by Another Device	13	13
Appropriate Device Problem Term/Code Not Available	12	12
Fitting Problem	10	10
Naturally Worn	10	10
Mechanical Jam	9	9
Material Split, Cut or Torn	8	8
Flaked	8	8
Positioning Failure	8	8
Device Dislodged or Dislocated	7	7
Component Missing	7	7
Mechanical Problem	6	6
Unintended Movement	6	6
Material Deformation	6	6
Difficult to Open or Close	5	5
Melted	5	5
Failure to Advance	5	5
Material Separation	5	5
Device Difficult to Maintain	5	5
Connection Problem	4	4
Failure to Cut	4	4
Contamination /Decontamination Problem	4	4
Inadequacy of Device Shape and/or Size	3	3
Incorrect Measurement	3	3
Insufficient Device Problem Information	3	3
Crack	3	3
Device-Device Incompatibility	3	3
Activation, Positioning or Separation Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Delivered as Unsterile Product	2	2
Pitted	2	2
Failure to Clean Adequately	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Material Erosion	2	2
Collapse	2	2
Device Damaged Prior to Use	2	2
Difficult to Insert	1	1
Overfill	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	979	985
Insufficient Information	320	321
Foreign Body In Patient	269	270
Device Embedded In Tissue or Plaque	50	50
Failure of Implant	17	17
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	15	15
Bone Fracture(s)	9	9
Unspecified Infection	7	7
Loss of fracture reduction	7	7
Pain	7	7
Unspecified Tissue Injury	6	6
Perforation	6	6
Low Blood Pressure/ Hypotension	4	4
Pericardial Effusion	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Cardiac Tamponade	3	3
Laceration(s)	3	3
Internal Organ Perforation	2	2
Heart Block	2	2
No Consequences Or Impact To Patient	2	2
Tissue Damage	2	2
Swelling/ Edema	2	2
Joint Laxity	2	2
Perforation of Vessels	2	2
Failure to Anastomose	2	2
Discomfort	2	2
Inflammation	2	2
Metal Related Pathology	2	2
Pneumothorax	2	2
Exposure to Body Fluids	1	1
Muscular Rigidity	1	1
Loss of Range of Motion	1	1
Cardiogenic Shock	1	1
No Known Impact Or Consequence To Patient	1	1
Osteopenia/ Osteoporosis	1	1
Nonunion/Delayed-union Bone Fracture	1	1
Increased Appetite	1	1
Obstruction/Occlusion	1	1
Synovitis	1	1
Subluxation	1	1
Hematoma	1	1
Vascular Dissection	1	1
Sepsis	1	1
Hypoxia	1	1
Joint Dislocation	1	1
Arthralgia	1	1
Bacterial Infection	1	1
Hip Fracture	1	1
Impaired Healing	1	1
Damage to Ligament(s)	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