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

Catalog Number CRANI-A

Device Problems Bent (1059); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during pre-surgery set-up it was observed that the craniotome device had a bent tip and would not accept burr devices.It was reported that there was no delay in a scheduled surgical procedure as a spare device was available for use.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device has a bent tip and will not accept burrs was confirmed.An assessment was performed on the device which found that the device failed cutter insertion as the cutter could not be fully inserted into the device.During repair it was observed that the tip of the device was drilled and bent and the bearings were worn out and broken.The failed cutter insertion is caused by the bearings being worn out and loose-creating a situation where the cutter is not able to be inserted.The bearings are no longer in axial alignment and do not allow the cutter to pass through.The drilled and bent tip is caused by the cutter being improperly loaded into the attachment and then installed onto the drill, the cutter does not seat properly in the locking chamber.The attachment can be forced into position which places the distal tip of the cutter in compression.At this point, the tip of the cutter is in direct contact with the neuro tip of the attachment.When the drill is started, the cutter drills into or through the neuro tip.It was determined that the condition of the bearings being worn out and broken was due to excessive force being applied to the device while it is in use.The assignable root cause was determined to be component damage caused by user error.If additional information should become available, a supplemental medwatch report 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: 6026171
• MDR Text Key: 57621774
• Report Number: 1045834-2016-12941
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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: 09/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2006
• 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