MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Model Number 212186

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

This pi is for case 2 of 3.All case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Update on (b)(6) 2019 wg: as reported by rep: "this has probably happened in all three tka cases that day.The patients were in the room but not quite completely under.Not sure how you would consider that in terms of being ¿under anesthesia¿ as they only really do spinals at this hospital.The solution hasn¿t been resolved.They are waiting for official word, but as for now if they continue to come up with the grease or gray stuff they are deeming them unsterile and rejecting them.The procedure was completed successfully.I do not need replacements unless you deem it necessary." case type unknown.

Manufacturer Narrative

Reported event: it was reported that all case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according to the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Product evaluation and results: not performed as no items were returned.The failure cannot be determined from the images provided in the communication log.Product history review: a review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 09/01/2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212186, lot 35020816 shows 1 additional complaint related to the failure in this investigation.The complaint is (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

Event Description

This pi is for case 2 of 3.All case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Update 12/november/2019 wg: as reported by rep: "this has probably happened in all three tka cases that day.The patients were in the room but not quite completely under.Not sure how you would consider that in terms of being ¿under anesthesia¿ as they only really do spinals at this hospital.The solution hasn¿t been resolved.They are waiting for official word, but as for now if they continue to come up with the grease or gray stuff they are deeming them unsterile and rejecting them.The procedure was completed successfully.I do not need replacements unless you deem it necessary.".Case type unknown.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9359801
• MDR Text Key: 176285314
• Report Number: 3005985723-2019-00820
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212186
• Device Catalogue Number: 212186
• Device Lot Number: 3500276 / 35020816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization