MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR; STEREOTACTIC DEVICE

Model Number N/A

Device Problems Failure to Fire (2610); Temperature Problem (3022)

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

Event Date 09/15/2015

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 partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case the anspach burr motor malfunctioned.The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned.The motor was exchanged for a third replacement motor.The case was then completed successfully.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: anspach emax 2 plus burr motor went down during a case.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was confirmed.Device history review: not performed as the anspach emax 2 plus burr motor is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding went down during a case failure of p/n: 110940, s/n: (b)(4).There have been no other events for the referenced serial number.Trend request for this part number has been submitted (trend request (b)(4)).Conclusions: the anspach emax 2 plus burr motor is an oem device.Upon receipt, the device was evaluated per (b)(4) anspach emax 2 plus burr motor and the reported event was confirmed.

Event Description

The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case the anspach burr motor malfunctioned.The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned.The motor was exchanged for a third replacement motor.The case was then completed successfully.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• 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: 5097854
• MDR Text Key: 26547587
• Report Number: 3005985723-2015-00170
• 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: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110940
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• 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): Required Intervention
• Patient Age: 71 YR