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

Catalog Number CRANI-A

Device Problems Break (1069); Component Missing (2306); Device Operates Differently Than Expected (2913); Naturally Worn (2988); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product made prior to compliance date; (b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of an undetermined malfunction was confirmed.An assessment was performed on the device which found that the device failed temperature tests (overheating to 122 degree; should be less than or equal to 118 degrees).During repair it was also observed that the bushing was worn and the bearings were worn.It was determined that this condition caused the overheating.The assignable root cause of this condition was determined to be due to normal wear over time.It was further determined that the cause of the crani-a drilled tip was due to a failure to follow the directions for use (dfu).It was determined that when the burr device was improperly loaded into the attachment device and then installed onto the drill device, the burr did not seat properly in the locking chamber.The attachment device could be 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.When the drill device was started, the burr device drilled into or through the neuro tip.The assignable root cause of the component damage was determined to be due to user error, abuse and /or misuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that the crani-a attachment device had an undetermined malfunction.During service and evaluation, it was observed that the crani-a attachment device failed temperature test, and it was found that the device had a drilled tip.During repair it was also observed that the bushing was worn and the bearings were worn.It was noted that the ball bearings had fallen apart, missing beads, the cage-does not exist and the crane bracket was damaged.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.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: 6134464
• MDR Text Key: 61450614
• Report Number: 1045834-2016-13298
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/10/2016

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: CRANI-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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