MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

As part of 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

During tha procedure, surgeon was impacting the cup and fractured the acetabulum.Surgeon pointed out that the bone quality was poor.Registration was 0.2.Patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting the hip procedure.While fixing the acetabulum he had a hard time get the screws fixated.Case was completed robotically.Surgical delay - 1 hr while placing plate and screw.

Manufacturer Narrative

Update to d2.Reported event: during tha procedure, surgeon was impacting the cup and fractured the acetabulum.Surgeon pointed out that the bone quality was poor.Registration was 0.2.Patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting the hip procedure.While fixing the acetabulum he had a hard time get the screws fixated case was completed robotically surgical delay 1 hr while placing plate and screw.Method & results: product evaluation and results: the acetabular fracture happened during the case, but no system malfunction was found based on the log analysis.Product history review: review of the device history records associated with rob173 indicate that on (b)(6) 2011 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tha software other.Conclusions: the acetabular fracture happened during the case, but no system malfunction was found based on the log analysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

During tha procedure, surgeon was impacting the cup and fractured the acetabulum.Surgeon pointed out that the bone quality was poor.Registration was 0.2 patient in (b)(6) 2018 had a hip fracture and had an omega plate/lag screw as well 7.2 cannulated screw.Hardware was removed prior to starting the hip procedure.While fixing the acetabulum he had a hard time get the screws fixated case was completed robotically surgical delay 1 hr while placing plate and screw.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8757830
• MDR Text Key: 149934706
• Report Number: 3005985723-2019-00487
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR