MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 05/09/2017

Event Type  Injury  

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

During a mako tka surgery, the mics powertool gave an onscreen overheating warning and the function of the mics powertool was intermittent until finally cutting power completely (like a chatter, power on/off repeatedly).Bone was sclerotic.Mps followed troubleshooting steps but last bone cut had to be completed manually because the mics powertool no longer had power.Application (pka/tha/tka) tka why was the patient¿s bone sclerotic? was it due to the issues that occurred with the mics handpiece? was it unrelated to the issue with the mics handpiece? ¿ please give a detailed explanation.Yes, bone was very hard/ sclerotic.The surgeon noted this when cutting the patella with a manual saw later.It is my guess that the sclerotic bone was related to the issues with the mics.There have been other cases with sclerotic bone and the cuts are not that easy to complete with the mics (slow to remove bone, chattering on-off of the mics perhaps because the blade was angling out of the stereotactic boundary).However, this is the first instance the mics gave an error message on screen for overheating and soon shut off completely.No recuts were done in this case and there was about 10minutes between the tibia and femoral distal cuts and the other 4 femur cuts.We had the warning messages on the last cut and ultimately lost mics power during the last femur cut.Why wasn¿t a second mics handpiece used to complete the case? only about a third portion of the last cut (anterior chamfer) remained and surgeon preferred manual saw than assembling a new mics.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation."reported event: it was reported that the handpiece did not work.Issue was noticed during case, therefor there was no case delay and no patient harm.Device history review: device history records indicate (b)(4) devices were manufactured under lot k08u3 and all were accepted into final stock on 12/21/2016.Complaint history review: a review of complaints related to parts in lot number k08u3, p/n 209063 shows no other complaint related to the failure in this investigation.The product was unavailable for inspection as the product was not returned.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: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.".

Event Description

During a mako tka surgery, the mics powertool gave an onscreen overheating warning and the function of the mics powertool was intermittent until finally cutting power completely (like a chatter, power on/off repeatedly).Bone was sclerotic.Mps followed troubleshooting steps but last bone cut had to be completed manually because the mics powertool no longer had power.(b)(4).Application (pka/tha/tka) tka.Why was the patient¿s bone sclerotic? was it due to the issues that occurred with the mics handpiece? was it unrelated to the issue with the mics handpiece? ¿ please give a detailed explanation.Yes, bone was very hard/ sclerotic.The surgeon noted this when cutting the patella with a manual saw later.It is my guess that the sclerotic bone was related to the issues with the mics.There have been other cases with sclerotic bone and the cuts are not that easy to complete with the mics (slow to remove bone, chattering on-off of the mics perhaps because the blade was angling out of the stereotactic boundary).However, this is the first instance the mics gave an error message on screen for overheating and soon shut off completely.No recuts were done in this case and there was about 10 minutes between the tibia and femoral distal cuts and the other 4 femur cuts.We had the warning messages on the last cut and ultimately lost mics power during the last femur cut.Why wasn¿t a second mics handpiece used to complete the case? only about a third portion of the last cut (anterior chamfer) remained and surgeon preferred manual saw than assembling a new mics.

• Brand Name: HANDPIECE MICS
• 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6568990
• MDR Text Key: 75266480
• Report Number: 3005985723-2017-00219
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K143752
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/14/2017
• 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): Other
• Patient Age: 64 YR