MAUDE Adverse Event Report: RENISHAW MAYFIELD NEUROMATE GEN III

Model Number	neuro mate v1.5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is not device related.Device was working as intended.This is a discrepancy within the ifu and affects: neuroinpsire neuromate module instructions for use (h-5630-3016 versions a2-a6); plan delivery usa instructions for use (h-5630-3050-a1).In move to trajectory, the bottom right image showing a negative offset is incorrect.The horizontal dotted lines in the image have incorrectly shifted downwards in the image.The image suggests that the tool length is taken from the top of the tool holder instead of the top of the guide bush.The difference in position of the back of the tool holder and the back of the bushing from the target is 2mm.This is in conflict with the other information provided and could cause confusion to the user.If this were to re-occur: first scenario: user experiences confusion and surgeon then carries out a confirmatory check leading to potential increase of general anaesthetic exposure to the patient.Second scenario: by using this incorrect datum position, the user could unintentionally create a 2mm positive offset from the intended position of the tool/implantable.Upon delivery, the tool/implantable would be positioned 2 mm beyond the distal end of the planned position.The resultant harm to the patient would range from minor damage to brain structures, to serious harm.Due to all additional information within the ifu being correct and the user-training provided, the likelihood of the user being aware of the need to account for this 2 mm difference is considered low.Field safety notice shall be sent to affected customers to notify users that all consideration of tool length should be measured from the back face of the bushing in all cases, and to contact renishaw should they have any queries.Corrected ifus and a software update correcting the electronic ifu shall be rolled out.
Event or Problem Description
While planning a case using the tip offset feature within the surgical planning software within the system, the surgeon noticed in the ifu that there is a discrepancy in a diagram identifying the robot datum point.While planning a case using the tip offset feature within the surgical planning software (neuroinspire) within the neuromate system, the surgeon noticed in the ifu that there is a discrepancy in a diagram identifying the robot datum point.In section 3.4, of the neuroinspire-neuromate ifu h-5630-3016-a4, the graphic in the lower right shows the datum point to be a surface on the tool holder, not on the guide bushing.This graphic differs from the information given through customer training, and in other parts of the ifu.The discrepancy caused a lack of confidence in the measurements.To resolve the confidence issue, during the case, the surgeon planned a target on the surface of the patient's scalp, tested the offsets, and distances using a measurement tool, confirming the robot datum to be on the back of the guide bushing.

• Brand Name: NEUROMATE GEN III
• Common Device Name: NEUROMATE
• Manufacturer (Section D): RENISHAW MAYFIELD; 31, rue ampère; chassieu, 69680 ; FR 69680
• MDR Report Key: 10660968
• Report Number: 3009108888-2020-00001
• Device Sequence Number: 16958674
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 181706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: neuro mate v1.5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other