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

Catalog Number EMAX2PLUS

Device Problems Power Problem (3010); Non Reproducible Results (4029)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

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

Mako product specialist reported that during a case, problems were encountered with the anspach.The burr lost power and began to come loose.Another equipment was used to complete the case.There was a delay of approximately 40 minutes because the hospital staff had internal trouble sourcing the equipment.Delay of approximately 40 minutes.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor burr lost power and began to come loose.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 burr lost power and began to come loose 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.

Event Description

Mako product specialist reported that during a case, problems were encountered with the anspach.The burr lost power and began to come loose.Another equipment was used to complete the case.There was a delay of approximately 40 minutes because the hospital staff had internal trouble sourcing the equipment.Delay of approximately 40 minutes.

• 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: 8785581
• MDR Text Key: 150857151
• Report Number: 3005985723-2019-00506
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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: MD6312953009
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR