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

Catalog Number 209063

Device Problems Mechanical Problem (1384); Power Problem (3010)

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

Event Date 12/10/2018

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

During case, right before cutting our first cut, distal femur, the misc hand piece (power) would not align and when surgeon pressed down on trigger it made a different noise and it would not align to the cut.After switching out to a different misc we were able to continue with case.Surgical delay: 20 "minute".Case type: tka.

Manufacturer Narrative

Reported event: it was reported that during case, right before cutting our first cut, distal femur, the misc hand piece (power) would not align and when surgeon pressed down on trigger it made a different noise and it would not align to the cut.After switching out to a different mics we were able to continue with case.Product evaluation and results: visual inspection: visual inspection was not performed as this was a functional failure.Functional inspection: functional inspection was performed, and the device failed the test.Per case number (b)(4).1.Unable to repair mics as with the new cable did not fix the issue.Disposition - (return to vendor).Rtv reason: sticky trigger.Product history review: device history records indicate (b)(4) devices were manufactured under lot k08oc and (b)(4) devices were accepted into final stock on 03/9/2017.A review of qt17- 03-0036 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 209063, prodex lot k080c shows 05 additional complaint(s) related to the failure in this investigation.Complaint (b)(4).Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.

Event Description

During case, right before cutting our first cut, distal femur, the misc hand piece (power) would not align and when surgeon pressed down on trigger it made a different noise and it would not align to the cut.After switching out to a different misc we were able to continue with case.Surgical delay: 20 minute.Case type: tka.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8202681
• MDR Text Key: 131611772
• Report Number: 3005985723-2018-00791
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 42020716/4200899
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization