MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ADULT CRANIOTOME, LARGE; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Model Number	CRANI-L-G1
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the neuro tip leg had been drilled into.Therefore, the reported condition was confirmed.It was further noted that the neuro tip leg is due to excessive lateral force being placed on the device causing the drill to flex and come into contact with the neuro tip leg and damaged caused by user error.The assignable root cause was determined to be due to user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that during service and repair pre-testing, it was observed that the craniotome device had a drilled leg.The event was not related to surgery.There was no patient involvement reported.There were no injuries or medical intervention associated with this event.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: ADULT CRANIOTOME, LARGE
• Common Device Name: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens 33410
• MDR Report Key: 7127747
• Report Number: 1045834-2017-50127
• Device Sequence Number: 1158956
• Product Code: HBC
• UDI-Device Identifier: 00845384016427
• UDI-Public: (01)00845384016427(11)140508
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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-L-G1
• Device Catalogue Number: CRANI-L-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1