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	982	983
Physical Resistance/Sticking	69	69
Material Twisted/Bent	59	59
Dull, Blunt	45	45
Entrapment of Device	43	43
Difficult to Remove	39	39
Detachment of Device or Device Component	38	38
Material Fragmentation	35	35
Adverse Event Without Identified Device or Use Problem	32	32
Fracture	27	30
Defective Device	24	24
Use of Device Problem	19	19
Corroded	18	18
Patient Device Interaction Problem	18	18
Mechanical Jam	15	15
Material Split, Cut or Torn	14	15
Device Damaged by Another Device	13	13
Appropriate Term/Code Not Available	11	11
Fitting Problem	11	11
Mechanical Problem	10	10
Flaked	10	10
Component Missing	9	9
Positioning Failure	8	8
Activation, Positioning or Separation Problem	7	8
Failure to Cut	7	7
Unintended Movement	6	6
Material Deformation	6	6
Difficult to Open or Close	6	6
Device Dislodged or Dislocated	6	6
Material Separation	6	6
Device Difficult to Maintain	5	5
Output Problem	5	5
Contamination /Decontamination Problem	5	5
Failure to Advance	5	5
Connection Problem	4	4
Melted	4	4
Crack	4	4
Inadequacy of Device Shape and/or Size	3	3
Device Damaged Prior to Use	3	3
Incorrect Measurement	3	3
Device-Device Incompatibility	3	3
Misfire	3	3
Insufficient Information	3	3
Naturally Worn	3	3
Separation Problem	3	3
Failure to Clean Adequately	2	2
Firing Problem	2	2
Material Integrity Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Failure to Fire	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	911	917
Insufficient Information	316	317
Foreign Body In Patient	255	256
Device Embedded In Tissue or Plaque	50	50
Failure of Implant	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Bone Fracture(s)	9	9
Unspecified Infection	7	7
Pain	7	7
Unspecified Tissue Injury	6	6
Perforation	6	6
Low Blood Pressure/ Hypotension	4	4
Hemorrhage/Bleeding	4	4
Pericardial Effusion	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
Obstruction/Occlusion	1	1
Increased Appetite	1	1
Synovitis	1	1
Subluxation	1	1
Hematoma	1	1
Vascular Dissection	1	1
Sepsis	1	1
Non-union Bone Fracture	1	1
Hypoxia	1	1
Joint Dislocation	1	1
Arthralgia	1	1
Hip Fracture	1	1
Bacterial Infection	1	1
Impaired Healing	1	1
Damage to Ligament(s)	1	1
Bruise/Contusion	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