TPLC - Total Product Life Cycle

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Device	broach
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTQ
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1182	1213
Break	749	765
Unintended Movement	287	287
Failure to Cut	203	203
Material Deformation	181	183
Naturally Worn	145	145
Difficult to Advance	118	118
Scratched Material	110	110
Structural Problem	77	77
Adverse Event Without Identified Device or Use Problem	60	60
No Apparent Adverse Event	53	53
Device Damaged Prior to Use	44	44
Material Integrity Problem	37	37
Fracture	36	37
Material Twisted/Bent	32	32
Illegible Information	29	29
Contamination /Decontamination Problem	29	29
Chemical Problem	28	28
Mechanical Jam	19	19
Missing Information	16	16
Difficult to Open or Close	15	15
Detachment of Device or Device Component	14	14
Entrapment of Device	10	10
Crack	9	9
Device Contaminated During Manufacture or Shipping	7	7
Device Dislodged or Dislocated	6	6
Off-Label Use	4	4
Corroded	4	4
Tear, Rip or Hole in Device Packaging	3	3
Positioning Failure	2	2
Defective Device	2	2
Inaccurate Information	2	2
Improper or Incorrect Procedure or Method	2	2
Device Slipped	2	2
Backflow	1	1
Use of Device Problem	1	1
Insufficient Device Problem Information	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
Device Damaged by Another Device	1	1
Positioning Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Separation Failure	1	1
Difficult to Open or Remove Packaging Material	1	1
Loose or Intermittent Connection	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2306	2341
Insufficient Information	329	330
Limb Fracture	29	29
Bone Fracture(s)	14	14
Unspecified Tissue Injury	14	14
Joint Dislocation	6	6
Foreign Body In Patient	4	4
Joint Laxity	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Unspecified Infection	3	3
Arthralgia	2	2
Pain	2	2
Deformity/ Disfigurement	2	2
Thrombosis/Thrombus	1	1
Bone Notching	1	1
Nerve Damage	1	1
Scar Tissue	1	1
Distress	1	1