MAUDE Adverse Event Report: MAKO SURGICAL CORP. MOTOR ASSY, J3 STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207569

Device Problems Mechanical Problem (1384); Output Problem (3005)

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

Event Date 08/13/2019

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

Case number: (b)(4), rob542 - mps (b)(6) reported error 24 and could not pass homing on m3. Case type: tka. Surgery was not completed robotically. Update: "yes, patient was involved. During approach mode, while aligning itself for the femur distal cut the saw blade made contact with the patient¿s distal femur. Surgeon noted that blade did make a mark on the patient¿s bone, however they did not consider it arm and that section of bone was removed during manual tka. Surgeon had already made his exposure and no cuts had been made with the robot, so when the robot failed a standard instrumented tka was preformed. " approximately 20 min delay.

• Brand Name: MOTOR ASSY, J3
• 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: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 8946572
• MDR Text Key: 156172450
• Report Number: 3005985723-2019-00610
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 207569
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 08/29/2019 Patient Sequence Number: 1