TPLC - Total Product Life Cycle

• Device: extractor
• Product Code: HWB
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	71	71
2015	78	78
2016	162	162
2017	239	239
2018	287	287
2019	320	320
2020	302	302
2021	322	322
2022	319	319
2023	350	350
2024	78	78

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1297	1297
Device-Device Incompatibility	346	346
Material Twisted/Bent	219	219
Material Deformation	171	171
Naturally Worn	148	148
Fracture	131	131
Mechanical Jam	70	70
Crack	61	61
Appropriate Term/Code Not Available	53	53
Bent	45	45
Material Fragmentation	41	41
Material Integrity Problem	28	28
Device Operates Differently Than Expected	23	23
Scratched Material	19	19
Entrapment of Device	19	19
Mechanical Problem	19	19
Difficult to Remove	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Dull, Blunt	17	17
Physical Resistance/Sticking	15	15
Corroded	14	14
Component Missing	13	13
Loose or Intermittent Connection	12	12
Detachment of Device or Device Component	12	12
Contamination /Decontamination Problem	11	11
Fitting Problem	10	10
Metal Shedding Debris	9	9
Connection Problem	9	9
No Apparent Adverse Event	9	9
Insufficient Information	6	6
Illegible Information	6	6
Device Damaged by Another Device	6	6
Device Slipped	6	6
Device Issue	5	5
Use of Device Problem	5	5
Unintended Movement	5	5
Difficult to Open or Close	4	4
Defective Device	4	4
Structural Problem	4	4
Disassembly	4	4
Difficult to Insert	3	3
Detachment Of Device Component	3	3
Failure to Align	3	3
Device Difficult to Maintain	3	3
Device Handling Problem	2	2
Component or Accessory Incompatibility	2	2
Mechanics Altered	2	2
Sticking	2	2
Peeled/Delaminated	2	2
Device Damaged Prior to Use	2	2
Improper or Incorrect Procedure or Method	1	1
Difficult To Position	1	1
Off-Label Use	1	1
Failure to Advance	1	1
Failure to Cut	1	1
Loss of or Failure to Bond	1	1
Failure To Adhere Or Bond	1	1
Degraded	1	1
Material Discolored	1	1
Disconnection	1	1
Misconnection	1	1
Unintended Collision	1	1
Material Distortion	1	1
Activation, Positioning or Separation Problem	1	1
Device Dislodged or Dislocated	1	1
Device Contamination with Chemical or Other Material	1	1
Human-Device Interface Problem	1	1
Compatibility Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Incomplete or Inadequate Connection	1	1
Activation Problem	1	1
Separation Problem	1	1
Misassembly by Users	1	1
Output Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1033	1033
No Consequences Or Impact To Patient	713	713
No Known Impact Or Consequence To Patient	270	270
No Information	159	159
No Code Available	143	143
Insufficient Information	75	75
No Patient Involvement	71	71
Not Applicable	42	42
Sedation	35	35
Device Embedded In Tissue or Plaque	32	32
Foreign Body In Patient	20	20
Failure of Implant	11	11
Bone Fracture(s)	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Blood Loss	5	5
Injury	4	4
Pain	4	4
Unspecified Infection	3	3
Discomfort	3	3
Non-union Bone Fracture	3	3
Muscle Weakness	2	2
Seroma	2	2
Tissue Damage	2	2
Cerebrospinal Fluid Leakage	2	2
Numbness	2	2
Patient Problem/Medical Problem	2	2
Unspecified Nervous System Problem	2	2
Unspecified Tissue Injury	2	2
Fall	1	1
Arthritis	1	1
Rheumatoid Arthritis	1	1
Joint Dislocation	1	1
Impaired Healing	1	1
Therapeutic Response, Decreased	1	1
Therapeutic Response, Increased	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Dec-28-2010
2	Innomed, Inc.	II	May-01-2024
3	Stryker Howmedica Osteonics Corp.	II	Apr-27-2010
4	Synthes, Inc.	II	Apr-25-2018