TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2018	1609	1609
2019	1550	1550
2020	1477	1477
2021	2006	2006
2022	2088	2088
2023	1557	1557

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7370	7370
Crack	997	997
Naturally Worn	666	666
Fracture	586	586
Device-Device Incompatibility	550	550
Material Twisted/Bent	336	336
Material Deformation	176	176
Scratched Material	174	174
Contamination /Decontamination Problem	146	146
Material Integrity Problem	104	104
Adverse Event Without Identified Device or Use Problem	71	71
Mechanical Jam	70	70
No Apparent Adverse Event	67	67
Appropriate Term/Code Not Available	55	55
Detachment of Device or Device Component	52	52
Unintended Movement	46	46
Component Missing	38	38
Loose or Intermittent Connection	37	37
Entrapment of Device	32	32
Illegible Information	25	25
Physical Resistance/Sticking	24	24
Device Contamination with Chemical or Other Material	21	21
Material Discolored	20	20
Failure to Disconnect	19	19
Connection Problem	19	19
Mechanical Problem	16	16
Device Slipped	12	12
Dull, Blunt	12	12
Difficult to Remove	11	11
Use of Device Problem	9	9
Insufficient Information	8	8
Structural Problem	7	7
Material Fragmentation	7	7
Corroded	6	6
Off-Label Use	6	6
Device Damaged by Another Device	6	6
Compatibility Problem	6	6
Device Dislodged or Dislocated	5	5
Defective Device	5	5
Deformation Due to Compressive Stress	5	5
Fitting Problem	5	5
Disassembly	5	5
Device Reprocessing Problem	5	5
Flaked	4	4
Defective Component	4	4
Device Issue	4	4
Material Split, Cut or Torn	4	4
Separation Problem	4	4
Positioning Problem	3	3
Device Damaged Prior to Use	3	3
Delivered as Unsterile Product	3	3
Degraded	3	3
Bent	3	3
Detachment Of Device Component	2	2
Difficult to Insert	2	2
Material Rupture	2	2
Material Disintegration	2	2
Improper or Incorrect Procedure or Method	2	2
Problem with Sterilization	2	2
Failure to Cut	2	2
Device Difficult to Maintain	2	2
Osseointegration Problem	2	2
Failure to Clean Adequately	2	2
Difficult or Delayed Separation	1	1
Missing Information	1	1
Device Fell	1	1
Device Handling Problem	1	1
Missing Test Results	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Protrusion/Extrusion	1	1
Device Or Device Fragments Location Unknown	1	1
Blocked Connection	1	1
Activation, Positioning or Separation Problem	1	1
Separation Failure	1	1
Loss of Osseointegration	1	1
Solder Joint Fracture	1	1
Residue After Decontamination	1	1
Material Separation	1	1
Product Quality Problem	1	1
Peeled/Delaminated	1	1
Device Difficult to Setup or Prepare	1	1
Disconnection	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5561	5561
No Consequences Or Impact To Patient	3980	3980
Insufficient Information	276	276
No Code Available	199	199
No Known Impact Or Consequence To Patient	187	187
Not Applicable	107	107
No Patient Involvement	89	89
No Information	49	49
Foreign Body In Patient	40	40
Device Embedded In Tissue or Plaque	8	8
Unspecified Infection	7	7
Pain	6	6
Injury	4	4
Failure of Implant	4	4
Bone Fracture(s)	3	3
Inadequate Osseointegration	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Musculoskeletal problem	1	1
Osteopenia/ Osteoporosis	1	1
Patient Problem/Medical Problem	1	1
Hematoma	1	1
Thrombosis	1	1
Non-union Bone Fracture	1	1
Joint Disorder	1	1
Reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Enztec Limited	II	Jan-24-2020
2	Exactech, Inc.	II	Jun-30-2023
3	Exactech, Inc.	II	Sep-10-2019
4	XTANT Medical	II	Jul-04-2020
5	Zimmer Biomet, Inc.	II	Feb-14-2018