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

Catalog Number EMAX2PLUS

Device Problems Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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

It was reported by the distributor that mps and surgeon were in the case, after completed the registration and balancing and begin to resect the bone.Before completing the cut the motor starts to fail, tried setting cutter and reengage the stereotactic boundaries a few times but not resolved.The distributor check the assembly of the motor to make sure its properly attach and run a burr status check, and the result was failed.Finally, another anspach motor as replacement and the case completed without any further issue.Surgery was delayed for about 45 mins because we need time to transport another sterile set of anspach motor urgently to the hospital.

Event Description

It was reported by the distributor that mps and surgeon were in the case, after completed the registration and balancing and begin to resect the bone.Before completing the cut the motor starts to fail, tried setting cutter and reengage the sterotactic boundaries a few times but not resolved.The distributor check the assembly of the motor to make sure its properly attach and run a burr status check, and the result was failed.Finally, another anspach motor as replacement and the case completed without any further issue.Surgery was delayed for about 45 mins because we need time to transport another sterile set of anspach motor urgently to the hospital.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor starts to fail, tried setting cutter and reengage the stereotactic boundaries a few times but not resolved.Method & results: -device evaluation and results: no device inspection could be completed as the product was not available for evaluation.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 starts to fail, tried setting cutter and reengage the stereotactic boundaries a few times but not resolved failure of p/n: emax2plus, s/n: (b)(6).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.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: 8790887
• MDR Text Key: 151047047
• Report Number: 3005985723-2019-00510
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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: K47312028214
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization