TPLC - Total Product Life Cycle

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Device	screwdriver
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HXX
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5123	5135
Material Twisted/Bent	3157	3160
Device-Device Incompatibility	1819	1822
Fracture	1055	1057
Material Deformation	801	801
Naturally Worn	591	593
Calibration Problem	276	276
Material Integrity Problem	271	273
Contamination /Decontamination Problem	212	212
Entrapment of Device	161	161
Mechanical Jam	113	115
Crack	112	112
Mechanical Problem	104	104
Detachment of Device or Device Component	104	104
Compatibility Problem	80	80
Material Separation	79	84
Material Fragmentation	65	65
Unintended Movement	57	57
Connection Problem	55	55
Use of Device Problem	52	52
Appropriate Term/Code Not Available	51	51
Packaging Problem	34	34
No Apparent Adverse Event	33	33
Device Slipped	33	33
Physical Resistance/Sticking	32	33
Component Missing	29	29
Defective Device	28	28
Adverse Event Without Identified Device or Use Problem	28	28
Illegible Information	25	25
Device Contamination with Chemical or Other Material	20	20
Delivered as Unsterile Product	19	19
Difficult to Remove	17	17
Corroded	16	16
Scratched Material	16	16
Material Discolored	15	15
Mechanics Altered	14	14
Loose or Intermittent Connection	13	13
Degraded	13	13
Insufficient Information	10	10
Dull, Blunt	10	10
Failure to Calibrate	9	9
Device Damaged Prior to Use	9	9
Device Handling Problem	9	9
Electrical /Electronic Property Problem	9	9
Improper or Incorrect Procedure or Method	9	9
Device Difficult to Setup or Prepare	9	9
Structural Problem	8	8
Noise, Audible	7	7
Fitting Problem	7	7
Material Disintegration	7	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8617	8641
No Consequences Or Impact To Patient	1837	1837
Insufficient Information	727	728
No Patient Involvement	686	686
No Known Impact Or Consequence To Patient	507	507
Foreign Body In Patient	342	342
No Code Available	200	200
Device Embedded In Tissue or Plaque	108	109
Not Applicable	87	87
No Information	79	79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Injury	21	21
Unspecified Tissue Injury	12	12
Failure of Implant	9	10
Patient Problem/Medical Problem	8	8
Hemorrhage/Bleeding	5	5
Bone Fracture(s)	4	4
Pain	4	4
Blood Loss	3	3
Perforation of Vessels	3	3
Skull Fracture	2	2
Exsanguination	2	2
Perforation	2	2
Spinal Cord Injury	2	2
Unspecified Infection	1	1
Impaired Healing	1	1
Skin Inflammation/ Irritation	1	1
Ossification	1	1
Paralysis	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Non-union Bone Fracture	1	1
Joint Laxity	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Jul-19-2022
2	Flower Orthopedics Corporation	II	Jun-01-2021
3	Synthes (USA) Products LLC	II	May-28-2024
4	Trilliant Surgical, LLC	II	Jan-10-2020
5	Zimmer Biomet, Inc.	II	Jul-04-2019