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

Catalog Number EMAX2PLUS

Device Problems Temperature Problem (3022); Non Reproducible Results (4029)

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

Event Date 12/17/2018

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

Anspach tempurature increases significantly while burring and was making an abnormal high pitch sound (i presume it was just dying).The burr also has black residue left on it.Surgical delay -16-30 minutes.Case type: pka.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor temperature increases significantly while burring and was making an abnormal high pitch sound.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was not 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 temperature increases significantly while burring and was making an abnormal high pitch sound 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 james moll (engineer, r&d robotics) and the reported event was not 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.

Event Description

Anspach tempurature increases significantly while burring and was making an abnormal high pitch sound (i presume it was just dying).The burr also has black residue left on it.Surgical delay -16-30 minutes.Case type: pka.

• 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: 8209245
• MDR Text Key: 131918769
• Report Number: 3005985723-2019-00003
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EMAX2PLUS
• Device Lot Number: K35311674611
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization