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

Catalog Number 110940

Device Problem Temperature Problem (3022)

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

Event Date 10/07/2015

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 overheated while burring.The back up burr motor was unavailable during the same case.The case was completed successfully.

Manufacturer Narrative

Based on the results of investigation.Reported event: anspach emax 2 plus burr motor kept over heating while burring.Method & results: device evaluation and results: device evaluation was not performed and the anspach emax 2 plus burr motor event was not confirmed (product not available).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 overheating failure of p/n 110940 s/n: n/a.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.The device was not evaluated and the reported event was not confirmed (product not 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 overheated while burring.The back up burr motor was unavailable during the same case.The case was completed successfully.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• Type of Device: STEREOTACTIC DEVICE, ACCESSORY
• 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: 5147157
• MDR Text Key: 28142693
• Report Number: 3005985723-2015-00191
• 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: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 110940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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