MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO; MOTOR, DRILL, PNEUMATIC - HANDPIECE

Catalog Number BLACKMAX-N

Device Problems Device Inoperable (1663); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is report 2 of 2 for the same event.It was reported that during an unspecified neuro surgery, it was observed that the attachment device "was not working" when in use with the motor device.According to the reporter ¿shavings¿ were ¿coming out¿ of the motor device.The reporter was not able to clarify if ¿ shavings¿ fell into the patient.It was unknown if there were any delays to the surgical procedure or if a spare device was available for use.There were no injuries reported.It was unknown to the reporter if medical intervention or prolonged hospitalization were required.The date of the event was unknown.Several attempts have been made to obtain additional information concerning the reported event; however, no additional information has been provided.A supplemental medwatch report will be submitted if further information is received.

Manufacturer Narrative

Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.A functional assessment was performed and the attachment meets operational specifications.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Upon further review of this complaint, it was determined that the reported event was incorrectly filed as a serious injury.Based on the review, it was not reported that metal shavings fell into the patient.Therefore, the reported event has been updated from a serious injury to a device malfunction.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
• Type of Device: MOTOR, DRILL, PNEUMATIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 3613506
• MDR Text Key: 4169985
• Report Number: 1045834-2014-11375
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1