MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO SURGICAL ARM; STEREOTACTIC DEVICE

Catalog Number 203999

Device Problems Bent (1059); Material Deformation (2976)

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

Event Date 09/28/2015

Event Type  malfunction  

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 was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the surgery, it was noted that the robot bracket was bent.Troubleshooting activities were performed by engineering and the case was converted to manual.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: the reported device is a rio robotic arm, catalog: 203999, serial number (b)(4).The failing part number is a jevin cable guide, catalog 201946.Method & results: device evaluation and results: per gsp 124365, the j3 binding was caused by a bent jevin bracket (p/n 201946).Device history review: review of the device history records indicate the rio was manufactured and accepted into final stock on (b)(6) 2014 with no reported discrepancies.Complaint history review: the catsweb and trackwise complaint databases were reviewed from 2011 to january 2016 for similar reported events regarding the catching of j3.There have been 15 other complaints, including 3 related ones associated with (b)(4) ((b)(4)).Conclusions: the failure mode was confirmed and attributed to a bent jevin bracket (201946).Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the surgery, it was noted that the robot bracket was bent.Troubleshooting activities were performed by engineering and the case was converted to manual.

• Brand Name: RIO SURGICAL ARM
• Type of Device: STEREOTACTIC DEVICE
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5185562
• MDR Text Key: 29797836
• Report Number: 3005985723-2015-00220
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 203999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other