TPLC - Total Product Life Cycle

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Device	motor, drill, pneumatic
Regulation Description	Pneumatic cranial drill motor.
Product Code	HBB
Regulation Number	882.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	938	1427
Detachment of Device or Device Component	664	713
No Apparent Adverse Event	197	198
Difficult to Insert	114	114
Material Puncture/Hole	109	109
Naturally Worn	106	106
Noise, Audible	99	99
Fluid/Blood Leak	83	382
Fracture	68	69
Vibration	67	67
Break	64	64
Output below Specifications	64	64
Physical Resistance/Sticking	57	58
Loss of Power	55	55
Difficult to Remove	54	54
Material Twisted/Bent	44	44
Unintended System Motion	37	37
Excessive Heating	36	36
Corroded	34	34
Device Remains Activated	34	34
Complete Loss of Power	29	29
Fail-Safe Did Not Operate	26	26
Electrical /Electronic Property Problem	25	25
Burst Container or Vessel	23	31
Appropriate Term/Code Not Available	20	20
Leak/Splash	16	16
Product Quality Problem	13	13
Mechanical Jam	13	13
Adverse Event Without Identified Device or Use Problem	11	11
Unintended Power Up	10	15
Smoking	10	10
Premature Separation	10	10
Material Deformation	10	10
Device Displays Incorrect Message	9	9
Misconnection	9	9
Material Rupture	8	8
Fail-Safe Problem	7	8
Material Fragmentation	6	6
Gas/Air Leak	4	4
Device-Device Incompatibility	4	4
Insufficient Information	3	3
Material Integrity Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Dull, Blunt	3	3
Degraded	3	3
Explosion	2	2
Energy Output Problem	2	2
Mechanical Problem	2	2
Device Reprocessing Problem	2	2
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2305	3155
Insufficient Information	120	256
Unintended Radiation Exposure	15	16
Burn(s)	11	11
Device Embedded In Tissue or Plaque	10	10
Chemical Exposure	6	6
Unspecified Infection	5	5
Unspecified Tissue Injury	5	5
Perforation	4	4
Cerebrospinal Fluid Leakage	3	3
Tinnitus	3	3
Pain	2	2
Partial thickness (Second Degree) Burn	2	4
Hemorrhage/Bleeding	2	2
Spinal Cord Injury	2	2
Nicks, cuts or tears of dura or other tissues by device	1	1
Muscle Weakness	1	1
Foreign Body In Patient	1	1
Oversedation	1	1
Intracranial Hemorrhage	1	1
Numbness	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Awareness during Anaesthesia	1	1
Paresis	1	1
Reaction	1	1
Bacterial Infection	1	1
Hormonal Imbalance	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap AG	II	Oct-02-2025