MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 6.5CM ADULT CRANI ATTACHMT; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Catalog Number CRANI-A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that something broke inside the device could not be confirmed.However, during evaluation, it was determined that the neuro-tip was drilled.It was determined that the issue with the drilled neuro-tip was failure to follow the directions for use.It was determined that when the burr device was improperly loaded into the attachment device and then installed onto the drill device, the burr device did not seat properly in the locking chamber.It was determined that the attachment device was forced into position which placed the distal tip of the burr device in compression.At this point, the tip of the burr device was in direct contact with the neuro-tip of the attachment device.It was determined that when the drill was started, the burr device drilled into or through the neuro-tip.The assignable root cause was determined to be due to component damage caused by user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that something broke inside the craniotome device.During in-house engineering evaluation, it was determined that the neuro-tip was drilled.There were no delays in the surgical procedure and a spare device was available for use.It was reported that the procedure was completed with no further issues.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 6.5CM ADULT CRANI ATTACHMT
• 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: 6941474
• MDR Text Key: 90177537
• Report Number: 1045834-2017-12205
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011444
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRANI-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1