MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6.5 CM ADULT ROTATING CRANIOTOME ATTACH; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Model Number	CRANI-A-R
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported from (b)(6) that the craniotome device was heating up during use.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The device availability was inadvertently documented as (b)(4) 2018 in the medwatch initial report.The date returned to manufacturer was corrected to (b)(4) 2018.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device history record review: a device history review was performed, and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, a visual and functional assessment was performed which found that the device failed the cutter insertion test due to worn out bearings and the neuro-tip foot had been drilled into and the color ring was faded.An assessment was performed which found that the bearings were worn out, creating a situation whereby the cutter was not able to be inserted.That was because the bearings were no longer in axial alignment not allowing the cutter device to pass through.It was determined that the failure was caused by worn out bearings (normal wear).It was further determined that the color ring was faded due to normal wear over time.It was determined that the cause of the craniotome foot drilled was due to failure to follow the directions for use.When the burr 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 was forced into position which placed the distal tip of the burr in compression.At that point, the tip of the burr was in direct contact with the neuro tip of the attachment.When the drill was started, the burr drilled into or through the neuro tip.The assignable root causes were determined to be due to user error (drilled neuro-tip foot) and by normal wear out from use (cannot insert cutter, and the faded color ring).If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 6.5 CM ADULT ROTATING CRANIOTOME ATTACH
• Common Device Name: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens 33410
• MDR Report Key: 7221769
• Report Number: 1045834-2018-50163
• Device Sequence Number: 1328670
• Product Code: HBC
• UDI-Device Identifier: 00845384001744
• UDI-Public: (01)00845384001744(11)140306
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2018

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
• Operator of Device: Health Professional
• Device Model Number: CRANI-A-R
• Device Catalogue Number: CRANI-A-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 07/17/2018; 10/23/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 07/20/2018; 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1