MAUDE Adverse Event Report: MAKO SURGICAL CORP. DIRECT POWER CONSOLE PACK; STEREOTACTIC DEVICE, ACCESSORY

Catalog Number 203030

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/16/2015

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 surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, it was reported that the hip power was consistently not working.The case was successfully completed and there was no harm to the patient.

Manufacturer Narrative

Reported event: direct power console pack not consistently working.Method & results: device evaluation and results: no device inspection could be completed as the device was not returned for evaluation.Device history review: not performed as the direct power console pack 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 the direct power console not consistently working.There has been one other similar event for the referenced catalog number (b)(4).Trend request for this part number has been submitted (trend request #(b)(4)).Conclusions: the direct power console pack is an oem device.The failure mode could not be confirmed because the device was not returned 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.Trend request #(b)(4) has been initiated to continue to monitor for events related to this device.Device was not available for evaluation.

Event Description

The surgeon was performing a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, it was reported that the hip power was consistently not working.The case was successfully completed and there was no harm to the patient.

• Brand Name: DIRECT POWER CONSOLE PACK
• Type of Device: STEREOTACTIC DEVICE, ACCESSORY
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5377918
• MDR Text Key: 36344582
• Report Number: 3005985723-2016-00025
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121064
• 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: 12/16/2015

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: 203030
• Device Lot Number: SN 1211-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other