TPLC - Total Product Life Cycle

• Device: washer, bolt nut
• Product Code: HTN
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	3
AKROS MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	5
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	4
ARTHROSURFACE, INC
	SUBSTANTIALLY EQUIVALENT	1
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CC-INSTRUMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CORACOID SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CYCLA ORTHOPEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
DALLEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
GM DOS REIS INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
INSTRATEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE, INC
	SUBSTANTIALLY EQUIVALENT	1
MORTISE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOHELIX SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
PANTHER ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH AND NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICRAFT LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
XIROS LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	33	33
2015	34	34
2016	43	43
2017	30	30
2018	47	47
2019	52	52
2020	81	81
2021	148	148
2022	85	85
2023	108	108
2024	67	67

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	274	274
Adverse Event Without Identified Device or Use Problem	178	178
Device-Device Incompatibility	31	31
Appropriate Term/Code Not Available	27	27
Device Dislodged or Dislocated	19	19
Device Slipped	16	16
Entrapment of Device	15	15
Detachment of Device or Device Component	15	15
Patient Device Interaction Problem	15	15
Migration	15	15
Difficult to Advance	14	14
Fracture	13	13
Device Operates Differently Than Expected	11	11
Insufficient Information	11	11
Material Separation	9	9
Migration or Expulsion of Device	8	8
Material Split, Cut or Torn	8	8
Physical Resistance/Sticking	7	7
Detachment Of Device Component	6	6
Patient-Device Incompatibility	6	6
Defective Device	5	5
Material Twisted/Bent	5	5
Difficult To Position	5	5
Difficult to Remove	5	5
Improper or Incorrect Procedure or Method	5	5
Failure to Advance	5	5
Use of Device Problem	4	4
Material Fragmentation	4	4
Unstable	3	3
Positioning Problem	3	3
No Apparent Adverse Event	3	3
Device Markings/Labelling Problem	3	3
Material Integrity Problem	3	3
Expulsion	3	3
Material Protrusion/Extrusion	2	2
Activation, Positioning or Separation Problem	2	2
Unintended Movement	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
Failure to Align	2	2
Expiration Date Error	2	2
Fitting Problem	2	2
Component Missing	2	2
Material Rupture	2	2
Loose or Intermittent Connection	2	2
Activation Problem	2	2
Separation Problem	1	1
Mechanical Problem	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Off-Label Use	1	1
Material Frayed	1	1
Knotted	1	1
Use of Incorrect Control/Treatment Settings	1	1
Failure To Adhere Or Bond	1	1
Bent	1	1
Cut In Material	1	1
Structural Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Stretched	1	1
Unraveled Material	1	1
Separation Failure	1	1
Failure to Form Staple	1	1
Metal Shedding Debris	1	1
Packaging Problem	1	1
Mechanical Jam	1	1
Naturally Worn	1	1
Torn Material	1	1
Power Problem	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
Misassembly by Users	1	1
Contamination /Decontamination Problem	1	1
Delivery System Failure	1	1
Device Damaged by Another Device	1	1
Compatibility Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	194	194
No Code Available	102	102
Pain	87	87
Insufficient Information	80	80
Failure of Implant	53	53
No Known Impact Or Consequence To Patient	40	40
Unspecified Infection	39	39
Foreign Body In Patient	31	31
Non-union Bone Fracture	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
No Consequences Or Impact To Patient	21	21
Impaired Healing	16	16
Bone Fracture(s)	15	15
No Information	13	13
Device Embedded In Tissue or Plaque	11	11
Joint Dislocation	10	10
Injury	10	10
Necrosis	10	10
Hypersensitivity/Allergic reaction	9	9
Discomfort	8	8
Reaction	8	8
Swelling	8	8
Loss of Range of Motion	7	7
Tissue Damage	5	5
Post Operative Wound Infection	5	5
Osteolysis	5	5
Limited Mobility Of The Implanted Joint	4	4
Implant Pain	4	4
Physical Asymmetry	4	4
Irritation	4	4
Inflammation	3	3
Foreign Body Reaction	3	3
Bacterial Infection	3	3
Wound Dehiscence	2	2
Abscess	2	2
Arthritis	2	2
Hematoma	2	2
Erythema	2	2
Fall	2	2
Fatigue	2	2
Damage to Ligament(s)	2	2
Nerve Damage	2	2
Rash	2	2
Swelling/ Edema	2	2
Not Applicable	2	2
No Patient Involvement	2	2
Arthralgia	2	2
Anxiety	2	2
Distress	2	2
Viral Infection	1	1
Sinus Perforation	1	1
Deformity/ Disfigurement	1	1
Complaint, Ill-Defined	1	1
Needle Stick/Puncture	1	1
Palpitations	1	1
Sleep Dysfunction	1	1
Weight Changes	1	1
Numbness	1	1
Sweating	1	1
Osteopenia/ Osteoporosis	1	1
Alteration In Body Temperature	1	1
Fluid Discharge	1	1
Patient Problem/Medical Problem	1	1
Limb Fracture	1	1
Staphylococcus Aureus	1	1
Scar Tissue	1	1
Increased Sensitivity	1	1
Ulceration	1	1
Tinnitus	1	1
Paresis	1	1
Pleural Effusion	1	1
Muscle Weakness	1	1
Muscular Rigidity	1	1
Headache	1	1
Autoimmune Disorder	1	1
Ossification	1	1
Erosion	1	1
Bradycardia	1	1
Cyst(s)	1	1
Purulent Discharge	1	1
Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	III	Sep-30-2016
2	Synthes USA HQ, Inc.	II	Nov-26-2013
3	TriMed Inc.	II	Feb-07-2023
4	Zimmer Biomet, Inc.	II	Nov-07-2019