MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE

Catalog Number BLACKMAX-N-LP

Device Problems Output below Specifications (3004); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device date of manufacture is unknown; therefore, udi: (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.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 motor device had damaged bearings, excessive noise level and damaged blades.It was further determined that the device failed pretest for initial rotational speed and noise verification.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).The device manufacture date was documented as unknown in the initial report.It has been updated to february 20, 2007.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 8370059
• MDR Text Key: 137243024
• Report Number: 1045834-2019-52961
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• PMA/PMN Number: K831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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 Number: BLACKMAX-N-LP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1