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

Model Number 212480

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 3 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.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9359940
• MDR Text Key: 176284493
• Report Number: 3005985723-2019-00831
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• 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

• Device Model Number: 212480
• Device Catalogue Number: 212480
• Device Lot Number: 3500781 / 35040117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 11/21/2019 Patient Sequence Number: 1