MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number EMAX2PLUS

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 01/10/2018

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 anspach did not work upon delivery.In an attempt to use the anspach (which was used for the first time out-of-box) as a replacement for a previously defective anspach unit, it would not activate the burr.Pka case delayed for 20 minutes.

Event Description

The anspach did not work upon delivery.In an attempt to use the anspach (which was used for the first time out-of-box) as a replacement for a previously defective anspach unit, it would not activate the burr.Pka case delayed for 20 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update.Reported event: anspach emax 2 plus burr motor did not work upon delivery; would not activate the burr.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 anspach emax 2 plus burr motor did not work upon delivery; would not activate the burr failure of p/n: emax2plus, s/n: (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the anspach emax 2 plus burr motor is an oem device.Upon receipt, the anspach emax 2 plus burr motor was bench evaluated by (b)(4) (engineer, r&d robotics) and the reported event was confirmed.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.

• Brand Name: ANSPACH® EMAX2 PLUS MOTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7251025
• MDR Text Key: 99796301
• Report Number: 3005985723-2018-00063
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMAX2PLUS
• Device Lot Number: K51312086911
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization