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 07/04/2017

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 motor was giving an overheating warning on the mako system (e6).This issue wasn't resolved after allowing it to cool for 30 seconds as suggested.After following protocol it was decided to replace the anspach motor.The surgical delay was 1 hour.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor was giving an overheating warning on the mako system (e6).Device evaluation and results: no device inspection could be completed as the product was not available for evaluation (lost product).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 was giving an overheating warning on the mako system (e6) failure of p/n: emax2plus, s/n: (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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.The device was not returned for evaluation.

Event Description

The anspach motor was giving an overheating warning on the mako system (e6).This issue wasn't resolved after allowing it to cool for 30 seconds as suggested.After following protocol it was decided to replace the anspach motor.The surgical delay was 1 hour.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6705442
• MDR Text Key: 79767983
• Report Number: 3005985723-2017-00287
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 12/01/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization