TPLC - Total Product Life Cycle

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Device	reamer
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTO
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14556	14556
Naturally Worn	1904	1904
Break	1574	1574
Corroded	1040	1040
Device-Device Incompatibility	713	713
No Apparent Adverse Event	703	703
Material Twisted/Bent	503	503
Adverse Event Without Identified Device or Use Problem	444	444
Dull, Blunt	390	390
Entrapment of Device	359	359
Illegible Information	306	306
Contamination /Decontamination Problem	170	170
Material Deformation	166	166
Fracture	87	87
Crack	84	84
Detachment of Device or Device Component	53	53
Degraded	51	51
Mechanical Jam	50	50
Scratched Material	50	50
Material Integrity Problem	34	34
Device Contaminated During Manufacture or Shipping	33	33
Loose or Intermittent Connection	24	24
Unintended Movement	21	21
Improper or Incorrect Procedure or Method	20	20
Component Missing	15	15
Material Discolored	14	14
Appropriate Term/Code Not Available	12	12
Inaccurate Information	10	10
Structural Problem	9	9
Use of Device Problem	9	9
Physical Resistance/Sticking	7	7
Difficult to Insert	5	5
Material Fragmentation	4	4
Device Slipped	4	4
Defective Device	3	3
Material Disintegration	3	3
Peeled/Delaminated	3	3
Off-Label Use	3	3
Mechanical Problem	3	3
Difficult to Remove	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Product Quality Problem	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Insufficient Information	2	2
Device Damaged Prior to Use	2	2
Difficult to Open or Remove Packaging Material	2	2
Difficult to Open or Close	2	2
Noise, Audible	2	2
Battery Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16953	16953
Insufficient Information	1384	1384
No Consequences Or Impact To Patient	959	959
Foreign Body In Patient	372	372
No Code Available	362	362
Not Applicable	42	42
Unspecified Tissue Injury	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Injury	22	22
Limb Fracture	20	20
Bone Fracture(s)	18	18
No Patient Involvement	17	17
No Known Impact Or Consequence To Patient	8	8
Failure of Implant	6	6
Pain	6	6
Unspecified Infection	5	5
Septic Shock	5	5
Loss of Range of Motion	4	4
Shock	4	4
Hemorrhage/Bleeding	4	4
Post Operative Wound Infection	3	3
Device Embedded In Tissue or Plaque	3	3
Discomfort	2	2
Fall	2	2
Non-union Bone Fracture	2	2
Swelling/ Edema	2	2
Hip Fracture	1	1
Hematoma	1	1
Unspecified Nervous System Problem	1	1
Burn(s)	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Hyperextension	1	1
Physical Entrapment	1	1
Perforation of Vessels	1	1
Tissue Damage	1	1
Skin Tears	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Synthes (USA) Products LLC	II	Mar-01-2024
2	Synthes (USA) Products LLC	II	Dec-15-2020
3	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.	II	Mar-20-2020
4	Zimmer, Inc.	II	Feb-06-2023