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

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Hip Fracture (2349)

Event Date 07/02/2020

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

The surgeon revised a hip stem due to femoral fracture.Original surgery was (b)(6) 2020.The rep provided primary and revision usage sheets and confirmed that no further information will be released.

Manufacturer Narrative

Reported event: it was reported that doctor revised a hip stem due to femoral fracture.Original surgery was (b)(6) 2020.Update (b)(6) 2020 wg: rep confirmed that no further information will be released by the hospital or surgeon.Product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review: a review of device history records shows that rob was inspected and accepted into stock on (b)(6) 2010 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in trackwise related to rob shows 0 complaint related to the failure in this investigation.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data, operative reports, progress notes and pre- & post-op x-rays are needed to complete the investigation for determining root cause.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

Event Description

The surgeon revised a hip stem due to femoral fracture.Original surgery was (b)(6) 2020.The rep provided primary and revision usage sheets and confirmed that no further information will be released.

• 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: 10329658
• MDR Text Key: 200634444
• Report Number: 3005985723-2020-00239
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR