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 Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the bearing of the craniotome device was failing.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that the bearings of the craniotome device were damaged.It was noted that ball bearing was disassembled,was missing balls and the cage was not available, the crani clamp was damaged, the color marks of the part had fallen off, the device fail-clamp, fail-clatter, and fail-ball bearing.During repair, it was determined that the device failed pretest for temperature, cutter insertion, lock operation and visual assessment.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Upon further evaluation, it was determined that the failure of the battery failing was confirmed.An assessment was performed which found that the device failed the cutter insertion assessment, and had a drilled neuro-tip leg and a drilled neuro-tip.During repair it was observed that the bearings were worn out, corroded and broken causing the device to fail the cutter insertion assessment.It was determined that the assignable root cause of this condition was due to normal wear over time.It was further determined that the issue with the drilled neuro-tip leg is indicative of excessive side loading causing the cutter to flex and to come in contact with the leg of the neuro-tip.The issue with the drilled neuro-tip was failure to follow the directions for use.When the burr is improperly loaded into the attachment and then installed onto the drill, the burr does not seat properly in the locking chamber.The attachment can be forced into position which places the distal tip of the burr in compression.At this point, the tip of the burr is in direct contact with the neuro-tip of the attachment.When the drill is started, the burr drills into or through the neuro-tip.The assignable root cause of this condition was determined to be due to 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: 6839505
• MDR Text Key: 84937269
• Report Number: 1045834-2017-11967
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• 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: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2014
• 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