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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE
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DEPUY SYNTHES PRODUCTS LLC BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE Back to Search Results
Catalog Number BLACKMAX-N-LP
Device Problems Output below Specifications (3004); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).This actual device was returned for evaluation.During repair it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the handpiece device had insufficient/low power and excessive noise.It was further determined that the device failed pretest for initial rotational speed and noise verification.It was noted in the service order that the device had an unspecified malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name
BLACKMAX-NEURO LOW PRESSURE
Type of Device
MOTOR, DRILL, PNEUMATIC - HANDPIECE
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
4500 riverside drive
palm beach gardens FL 33410
Manufacturer (Section G)
DEPUY SYNTHES PRODUCTS LLC
4500 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
kara ditty-bovard
4500 riverside drive
palm beach gardens, FL 33410
6103142063
MDR Report Key8727435
MDR Text Key148967188
Report Number1045834-2019-53900
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K831756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberBLACKMAX-N-LP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Initial Date Manufacturer Received 06/14/2019
Initial Date FDA Received06/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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