TPLC - Total Product Life Cycle

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Device	drills, burrs, trephines & accessories (compound, powered)
Product Code	HBF
Regulation Number	882.4305
Device Class	2

Premarket Reviews
Manufacturer	Decision
EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.
	SUBSTANTIALLY EQUIVALENT	1
EVONOS GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Auto Stop	304	304
Device Remains Activated	299	299
Fail-Safe Did Not Operate	171	171
Activation, Positioning or Separation Problem	166	166
Mechanical Problem	62	62
Break	53	53
Material Separation	29	29
Dull, Blunt	20	20
No Apparent Adverse Event	9	9
Adverse Event Without Identified Device or Use Problem	9	10
Fracture	8	8
Activation Problem	6	6
Entrapment of Device	6	6
Overheating of Device	5	5
Insufficient Information	5	5
Defective Device	5	5
Difficult to Remove	5	5
Use of Device Problem	5	5
Loss of Power	4	4
Positioning Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Integrity Problem	4	4
Failure to Shut Off	4	4
Protective Measures Problem	4	4
Electrical /Electronic Property Problem	3	3
Mechanical Jam	3	3
Detachment of Device or Device Component	3	3
Separation Problem	3	3
Appropriate Term/Code Not Available	3	3
Material Fragmentation	3	3
Material Disintegration	3	3
Separation Failure	3	3
Physical Resistance/Sticking	3	3
Failure to Cut	2	2
Particulates	2	2
Unintended Movement	2	2
Vibration	2	2
Peeled/Delaminated	2	2
Failure to Eject	2	2
Flaked	2	2
Premature Activation	2	2
Misconnection	2	2
Device Dislodged or Dislocated	1	1
Material Perforation	1	1
Unintended Ejection	1	1
Failure to Align	1	1
Fail-Safe Problem	1	1
Device Slipped	1	1
Material Erosion	1	1
Complete Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	330	330
Perforation	207	207
Brain Injury	120	120
No Known Impact Or Consequence To Patient	115	115
Injury	104	104
Abrasion	72	72
No Consequences Or Impact To Patient	67	67
Insufficient Information	64	64
Tissue Damage	58	58
Hemorrhage/Bleeding	48	48
Contusion	21	21
No Information	21	21
Unspecified Tissue Injury	13	13
Laceration(s)	10	10
Rupture	9	9
No Patient Involvement	9	9
Spinal Cord Injury	9	9
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Bruise/Contusion	7	7
Hematoma	4	4
Chemical Exposure	3	3
Patient Problem/Medical Problem	3	3
Unintended Radiation Exposure	3	3
Sinus Perforation	2	2
No Code Available	2	2
Intracranial Hemorrhage	2	2
Convulsion/Seizure	2	2
Dysphasia	2	2
Vascular Dissection	1	1
Skull Fracture	1	1
Inflammation	1	1
Radiation Exposure, Unintended	1	1
Intraocular Pressure Increased	1	1
Unspecified Nervous System Problem	1	1
Speech Disorder	1	1
Paralysis	1	1
Flashers	1	1
Visual Disturbances	1	1
Stroke/CVA	1	1
Hemostasis	1	1
Coma	1	1
Perforation of Vessels	1	1
Damage to Ligament(s)	1	1
Cerebrospinal Fluid Leakage	1	1
Intraocular Pressure Decreased	1	1
Therapeutic Effects, Unexpected	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Instruments Div. of Stryker Corporation	II	Nov-06-2020