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	2010	2010
2022	1687	1687

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7012	7012
Crack	875	875
Fracture	566	566
Naturally Worn	463	463
Device-Device Incompatibility	405	405
Material Twisted/Bent	337	337
Scratched Material	150	150
Material Deformation	146	146
Appropriate Term/Code Not Available	130	130
Contamination /Decontamination Problem	127	127
Adverse Event Without Identified Device or Use Problem	68	68
Material Integrity Problem	50	50
Detachment of Device or Device Component	49	49
Mechanical Jam	48	48
Component Missing	48	48
Loose or Intermittent Connection	43	43
Connection Problem	38	38
Unintended Movement	35	35
Insufficient Information	32	32
Entrapment of Device	26	26
Physical Resistance/Sticking	24	24
Device Contamination with Chemical or Other Material	22	22
Difficult to Remove	20	20
Mechanical Problem	19	19
No Apparent Adverse Event	19	19
Failure to Disconnect	17	17
Dull, Blunt	16	16
Material Discolored	16	16
Disassembly	14	14
Material Fragmentation	14	14
Illegible Information	14	14
Device Slipped	12	12
Use of Device Problem	10	10
Detachment Of Device Component	10	10
Bent	7	7
Device Operates Differently Than Expected	7	7
Device Damaged by Another Device	7	7
Structural Problem	6	6
Defective Device	6	6
Corroded	6	6
Device Reprocessing Problem	6	6
Fitting Problem	6	6
Device Damaged Prior to Use	5	5
Off-Label Use	5	5
Compatibility Problem	5	5
Device Issue	4	4
Defective Component	4	4
Flaked	4	4
Degraded	4	4
Positioning Problem	4	4
Separation Problem	4	4
Material Split, Cut or Torn	3	3
Delivered as Unsterile Product	3	3
Difficult to Insert	3	3
Device Difficult to Setup or Prepare	3	3
Deformation Due to Compressive Stress	3	3
Failure to Cut	2	2
Device Dislodged or Dislocated	2	2
Improper or Incorrect Procedure or Method	2	2
Problem with Sterilization	2	2
Sticking	2	2
Material Rupture	2	2
Material Disintegration	2	2
Device Difficult to Maintain	2	2
Failure to Clean Adequately	2	2
Missing Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Handling Problem	1	1
Missing Test Results	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Difficult or Delayed Separation	1	1
Device Fell	1	1
Fluid/Blood Leak	1	1
Failure to Discharge	1	1
Disconnection	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1
Peeled/Delaminated	1	1
Pitted	1	1
Imprecision	1	1
Misconnection	1	1
Device Disinfection Or Sterilization Issue	1	1
Material Protrusion/Extrusion	1	1
Osseointegration Problem	1	1
Solder Joint Fracture	1	1
Split	1	1
Loss of Osseointegration	1	1
Device Or Device Fragments Location Unknown	1	1
Blocked Connection	1	1
Separation Failure	1	1
Delamination	1	1
Activation, Positioning or Separation Problem	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	3700	3700
No Information	854	854
No Known Impact Or Consequence To Patient	526	526
No Code Available	206	206
Insufficient Information	179	179
Not Applicable	109	109
No Patient Involvement	105	105
Foreign Body In Patient	40	40
Device Embedded In Tissue or Plaque	13	13
Pain	6	6
Unspecified Infection	5	5
Failure of Implant	4	4
Injury	4	4
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
Osteopenia/ Osteoporosis	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