MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.85MM X 16 MM FRTR,CRNA; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	A-CRN-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 confirmed.A visual and functional assessment was performed on the device which found that the cutter device could not be removed due to worn out bearings.It was observed that the reason that the cutter could not be removed was because the bearings were worn out, causing the cutter to become stuck.It was further determined that the failure was caused by worn out bearings from normal wear.It was further determined that the neuro-tip leg was due to excessive lateral force placed on the device causing the drill to flex and come into contact with the neuro-tip leg.It was determined that the damage was caused by user error.The evidence showed that the excessive lateral force was what caused the cutter to fracture.It was observed that the bottom of the leg had been drilled into and it showed when the cutter broke, it cut into the upper part of the leg (same area that the cutter was broken).The assignable root cause was determined to be due to user error.If additional information should become available, a suplemental medwatch will be submitted accordingly.
Event or Problem Description
This is report 2 of 2 for the same event: it was reported that the cutter device was stuck in the shaft of the craniotome device.During in-house engineering evaluation, it was determined that the cutter device could not be removed from the craniotome device due to worn out bearings and the neuro-tip leg had been drilled into.It was further determined that the cutter was fractured.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 this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 1.85MM X 16 MM FRTR,CRNA
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7966480
• Report Number: 1045834-2018-51857
• Device Sequence Number: 170213
• Product Code: HBE
• UDI-Device Identifier: 00845384012603
• UDI-Public: (01)00845384012603(11)180306(10)L473127756
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113476
• 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): 08/21/2018

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 Expiration Date: 01/31/2023
• Device Model Number: A-CRN-G1
• Device Catalogue Number: A-CRN-G1
• Device Lot Number: L473127756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1