TPLC - Total Product Life Cycle

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Device	guide, surgical, instrument
Regulation Description	Manual surgical instrument for general use.
Product Code	FZX
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1734	1734
Break	943	943
Adverse Event Without Identified Device or Use Problem	606	606
Material Deformation	413	413
Material Twisted/Bent	277	277
Fracture	173	173
Unstable	161	161
Mechanical Jam	100	100
Device Contaminated During Manufacture or Shipping	94	94
Entrapment of Device	71	71
Material Integrity Problem	69	69
Use of Device Problem	49	49
Detachment of Device or Device Component	44	44
Packaging Problem	41	41
Contamination /Decontamination Problem	32	32
No Apparent Adverse Event	31	31
Crack	27	27
Device Slipped	20	20
Mechanical Problem	19	19
Material Separation	19	19
Appropriate Term/Code Not Available	18	18
Corroded	17	17
Failure to Align	15	15
Degraded	15	15
Connection Problem	15	15
Tear, Rip or Hole in Device Packaging	13	13
Defective Device	13	13
Separation Failure	11	11
Physical Resistance/Sticking	10	10
Device Markings/Labelling Problem	10	10
Manufacturing, Packaging or Shipping Problem	10	10
Component Missing	9	9
Incomplete or Inadequate Connection	9	9
Scratched Material	8	8
Loose or Intermittent Connection	8	8
Difficult to Remove	6	6
Positioning Failure	6	6
Improper or Incorrect Procedure or Method	6	6
Difficult to Advance	5	5
Unsealed Device Packaging	4	4
Unintended Movement	4	4
Naturally Worn	4	4
Device Handling Problem	4	4
Compatibility Problem	4	4
Fitting Problem	4	4
Failure to Cut	4	4
Difficult or Delayed Separation	3	3
Inaccurate Information	3	3
Noise, Audible	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2866	2866
No Consequences Or Impact To Patient	316	316
Insufficient Information	291	291
Unspecified Infection	241	241
Joint Laxity	235	235
No Patient Involvement	156	156
Foreign Body In Patient	98	98
No Known Impact Or Consequence To Patient	92	92
Implant Pain	48	48
No Code Available	45	45
Injury	20	20
Bone Fracture(s)	16	16
No Information	16	16
Failure of Implant	15	15
Loss of Range of Motion	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Tissue Injury	12	12
Fall	10	10
Pain	7	7
Tissue Damage	5	5
Muscle/Tendon Damage	5	5
Device Embedded In Tissue or Plaque	4	4
Joint Dislocation	4	4
Limb Fracture	3	3
Hypersensitivity/Allergic reaction	3	3
Not Applicable	3	3
Inflammation	3	3
Hematoma	3	3
Burn(s)	2	2
Muscular Rigidity	2	2
Swelling	2	2
Osteolysis	2	2
Numbness	2	2
Scar Tissue	2	2
Cramp(s) /Muscle Spasm(s)	1	1
Reaction to Medicinal Component of Device	1	1
Fatigue	1	1
Rupture	1	1
Arthralgia	1	1
Fever	1	1
Osteomyelitis	1	1
Wound Dehiscence	1	1
Purulent Discharge	1	1
Anemia	1	1
Abrasion	1	1
Perforation	1	1
Awareness during Anaesthesia	1	1
Cyst(s)	1	1
Brain Injury	1	1
Abscess	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hologic, Inc	II	Dec-11-2024
2	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-18-2024