TPLC - Total Product Life Cycle

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Device	instrument, cutting, orthopedic
Regulation Description	Manual surgical instrument for general use.
Product Code	HTZ
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	295	295
Device-Device Incompatibility	240	240
Material Deformation	183	183
Naturally Worn	158	158
Scratched Material	35	35
Mechanical Jam	27	27
Crack	25	25
Material Integrity Problem	25	25
Material Twisted/Bent	25	25
Corroded	16	16
Detachment of Device or Device Component	14	14
Contamination /Decontamination Problem	12	12
Illegible Information	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Failure to Cut	9	9
Physical Resistance/Sticking	8	8
No Apparent Adverse Event	7	7
Patient-Device Incompatibility	5	5
Entrapment of Device	4	4
Unintended Movement	4	4
Structural Problem	4	4
Material Discolored	3	3
Incorrect Measurement	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Problem	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	2	2
Device Slipped	1	1
Off-Label Use	1	1
Difficult to Advance	1	1
Positioning Problem	1	1
Difficult to Remove	1	1
Material Fragmentation	1	1
Device Dislodged or Dislocated	1	1
Self-Activation or Keying	1	1
Difficult to Open or Close	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	774	774
Insufficient Information	100	100
No Consequences Or Impact To Patient	51	51
No Patient Involvement	12	12
No Code Available	9	9
Not Applicable	5	5
Foreign Body In Patient	3	3
Unspecified Tissue Injury	3	3
Post Operative Wound Infection	2	2
Hemorrhage/Bleeding	2	2
Joint Dislocation	1	1
Failure of Implant	1	1
Bone Fracture(s)	1	1
Paralysis	1	1
Nerve Damage	1	1
Pain	1	1
Cerebrospinal Fluid Leakage	1	1
Spinal Cord Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Orthopaedics, Inc.	II	Feb-13-2020