MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 6.5CM ADLT CRANI,THIN FT PLATE; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Catalog Number CRANI-A-01_LL

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 10/29/2014

Event Type  Injury  

Event Description

This is report 8 of 8 for the same event: it was reported that during an unspecified pediatric surgery, it was observed that when using the cutting burr device, motor device and attachment device, it was observed that a black fluid sprayed from the attachment device into the field.The reporter stated that it remained unclear as to which of the six attachment devices was in use at the time of the event.There was a delay to the surgical procedure; however, the time of delay was unknown to the reporter.There was an identical spare motor device available for use.There was patient involvement reported.It was not reported if there were injuries or prolonged hospitalization.However, the patient was treated with unknown antibiotics.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that there was foreign debris in the lumen of the device.It was determined that during use, irrigation fluid wicks up the shaft of the cutter device and mixes with the debris inside the attachment.When the drill is stopped, the fluid runs out the distal tip of the attachment device and has a black tint to it.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning which was misuse, abuse, and/ or user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.5CM ADLT CRANI,THIN FT PLATE
• Type of Device: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• 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: 4266309
• MDR Text Key: 19764658
• Report Number: 1045834-2014-14851
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRANI-A-01_LL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE; CUTTER DEVICE
• Patient Outcome(s): Required Intervention