TPLC - Total Product Life Cycle

• Device: tap, bone
• Product Code: HWX
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	43	43
2015	66	66
2016	72	72
2017	43	43
2018	52	52
2019	125	125
2020	85	85
2021	91	91
2022	91	91
2023	84	84
2024	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	424	424
Device-Device Incompatibility	157	157
Fracture	51	51
Contamination /Decontamination Problem	48	48
Material Fragmentation	25	25
Entrapment of Device	15	15
Detachment Of Device Component	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Crack	8	8
Failure To Adhere Or Bond	8	8
Device Contamination with Chemical or Other Material	7	7
Device Operates Differently Than Expected	6	6
Failure to Cut	6	6
Difficult to Remove	6	6
Mechanical Jam	6	6
Material Integrity Problem	5	5
Material Twisted/Bent	5	5
Use of Device Problem	4	4
Material Separation	3	3
Component Missing	3	3
Dull, Blunt	3	3
Detachment of Device or Device Component	3	3
Difficult to Insert	3	3
Material Deformation	3	3
Appropriate Term/Code Not Available	3	3
Device Handling Problem	3	3
No Apparent Adverse Event	2	2
Material Split, Cut or Torn	2	2
Sticking	2	2
Naturally Worn	2	2
Material Frayed	2	2
Bent	2	2
Compatibility Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Expulsion	1	1
Device Damaged by Another Device	1	1
Device Or Device Fragments Location Unknown	1	1
Patient-Device Incompatibility	1	1
Device Slipped	1	1
Metal Shedding Debris	1	1
Fitting Problem	1	1
Component Falling	1	1
Corroded	1	1
Retraction Problem	1	1
Migration or Expulsion of Device	1	1
Particulates	1	1
Material Puncture/Hole	1	1
Device Difficult to Maintain	1	1
Physical Resistance/Sticking	1	1
Insufficient Information	1	1
Noise, Audible	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	271	271
No Consequences Or Impact To Patient	144	144
No Known Impact Or Consequence To Patient	138	138
No Patient Involvement	115	115
Foreign Body In Patient	34	34
Device Embedded In Tissue or Plaque	29	29
No Code Available	23	23
Insufficient Information	9	9
Bone Fracture(s)	8	8
Sedation	7	7
No Information	7	7
Injury	6	6
Failure of Implant	4	4
Pain	3	3
Unspecified Infection	2	2
Non-union Bone Fracture	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Not Applicable	1	1
Post Operative Wound Infection	1	1
Patient Problem/Medical Problem	1	1
Nerve Damage	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Blackstone Medical, Inc.	II	May-19-2010
2	Orthohelix Surgical Designs Inc	II	Nov-26-2010
3	Smith & Nephew Inc	II	Jun-06-2012
4	Sterilmed Inc	II	Jan-13-2009
5	Surgical Instrument Service And Savings, Inc.	II	Jul-01-2013
6	Zimmer GmbH	II	May-23-2019