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 Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

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 wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the rotations per minute of the handpiece device were below specification, there was a hole/cut in the hose of the device, and the device had an excessive noise level (db).It was noted that the device was too loud, had too little speed, and holes in the hose.It was further determined that the device failed pretest for initial rotation speed, and noise verification.It was noted in the service order that the device had an undetermined malfunction while being used with the compact speed reducer device, a craniotome device, and attachment devices.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

• 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 Key: 8473028
• MDR Text Key: 140606224
• Report Number: 1045834-2019-53310
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00845384001102
• UDI-Public: 845384001102
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2019

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: 01/16/2019
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/02/2019
• Date Device Manufactured: 04/20/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICES.; COMPACT SPEED REDUCER DEVICE.; CRANIOTOME DEVICE.