TPLC - Total Product Life Cycle

• Device: impactor
• Product Code: HWA
• Regulation Number: 888.4540
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	1404	1404
2018	1609	1609
2019	1550	1550
2020	1477	1477
2021	2009	2009
2022	835	835

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6366	6366
Crack	805	805
Fracture	519	519
Device-Device Incompatibility	364	364
Naturally Worn	363	363
Material Twisted/Bent	334	334
Scratched Material	146	146
Material Deformation	136	136
Appropriate Term/Code Not Available	130	130
Contamination /Decontamination Problem	114	114
Adverse Event Without Identified Device or Use Problem	63	63
Component Missing	47	47
Detachment of Device or Device Component	45	45
Loose or Intermittent Connection	43	43
Material Integrity Problem	42	42
Mechanical Jam	42	42
Connection Problem	38	38
Unintended Movement	33	33
Insufficient Information	32	32
Entrapment of Device	24	24
Physical Resistance/Sticking	23	23
Device Contamination with Chemical or Other Material	22	22
Difficult to Remove	19	19
Mechanical Problem	18	18
Dull, Blunt	16	16
Failure to Disconnect	15	15
Material Discolored	15	15
Disassembly	14	14
Material Fragmentation	12	12
Device Slipped	12	12
Use of Device Problem	10	10
Detachment Of Device Component	10	10
No Apparent Adverse Event	9	9
Illegible Information	9	9
Bent	7	7
Device Operates Differently Than Expected	7	7
Device Damaged by Another Device	7	7
Defective Device	6	6
Structural Problem	6	6
Corroded	6	6
Device Reprocessing Problem	6	6
Fitting Problem	6	6
Device Damaged Prior to Use	5	5
Defective Component	4	4
Degraded	4	4
Off-Label Use	4	4
Device Issue	4	4
Compatibility Problem	4	4
Separation Problem	4	4
Positioning Problem	4	4
Material Split, Cut or Torn	3	3
Flaked	3	3
Delivered as Unsterile Product	3	3
Device Difficult to Setup or Prepare	3	3
Difficult to Insert	2	2
Problem with Sterilization	2	2
Sticking	2	2
Material Rupture	2	2
Material Disintegration	2	2
Device Dislodged or Dislocated	2	2
Device Difficult to Maintain	2	2
Failure to Cut	2	2
Deformation Due to Compressive Stress	2	2
Failure to Clean Adequately	2	2
Difficult or Delayed Separation	1	1
Missing Information	1	1
Device Fell	1	1
Missing Test Results	1	1
Explosion	1	1
Delamination	1	1
Device Or Device Fragments Location Unknown	1	1
Blocked Connection	1	1
Separation Failure	1	1
Solder Joint Fracture	1	1
Split	1	1
Loss of Osseointegration	1	1
Osseointegration Problem	1	1
Material Protrusion/Extrusion	1	1
Device Disinfection Or Sterilization Issue	1	1
Fluid Leak	1	1
Failure to Discharge	1	1
Disconnection	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1
Improper or Incorrect Procedure or Method	1	1
Peeled/Delaminated	1	1
Pitted	1	1
Imprecision	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	4231	4231
No Clinical Signs, Symptoms or Conditions	2880	2880
No Information	854	854
No Known Impact Or Consequence To Patient	526	526
No Code Available	206	206
Insufficient Information	146	146
Not Applicable	109	109
No Patient Involvement	105	105
Foreign Body In Patient	38	38
Device Embedded In Tissue or Plaque	13	13
Pain	6	6
Injury	4	4
Unspecified Infection	4	4
Failure of Implant	3	3
Bone Fracture(s)	3	3
Reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hematoma	1	1
Sedation	1	1
Non-union Bone Fracture	1	1
Joint Disorder	1	1
Thrombosis	1	1
Inadequate Osseointegration	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Mar-08-2017
2	Enztec Limited	II	Jan-24-2020
3	Exactech, Inc.	II	Sep-10-2019
4	XTANT Medical	II	Jul-04-2020
5	Zimmer Biomet, Inc.	II	Feb-14-2018