MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH INTEGRATION PACKAGING ASSEMBLY; STEREOTACTIC DEVICE, ROBOTIC

Catalog Number 203909

Device Problems Computer Software Problem (1112); Failure to Deliver (2338)

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

Event Date 02/01/2016

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 partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the surgery, the ee trigger and the burr stopped and displayed error messages,therefore the software was reset to troubleshoot the software error that occurred multiple times.There was a case delay of approximately 25 minutes, backup robot was brought in to complete the case.The outcome of the case was successful.

Manufacturer Narrative

Device identification: the reported device was confirmed to be a anspach integration packaging assembly, p/n 203909, lot rob256, rma 227777.Device history review: review of the device history records indicate the robot containing this assembly was manufactured and accepted into final stock on 7/17/2013.Device evaluation and results: according to (b)(4), the field service engineer (fse) confirmed the anspach motor would not spin, even under burr override.Complaint history review: a review of complaints related to p/n 203909, lot number rob256 shows no additional complaints related to the failure in this investigation.Tracking of complaints related to the 203909 part number will be tracked (b)(4).Conclusions: the failure was confirmed by the fse.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

The surgeon was performing a makoplasty partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the surgery, the ee trigger and the burr stopped and displayed error messages,therefore the software was reset to troubleshoot the software error that occurred multiple times.There was a case delay of approximately 25 minutes, backup robot was brought in to complete the case.The outcome of the case was successful.

• Brand Name: ANSPACH INTEGRATION PACKAGING ASSEMBLY
• Type of Device: STEREOTACTIC DEVICE, ROBOTIC
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5405332
• MDR Text Key: 37337873
• Report Number: 3005985723-2016-00048
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 203909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2016
• 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