MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112230
Medical Device Problem Codes	Material Integrity Problem (2978); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The vizadiscs pop off the array when impacting the cup.This has occurred previously and were placed back on to finish cases.Dr cornelius asked that i have the array replaced now that is has reoccurred.Case type: tha.
Additional Manufacturer Narrative
Reported event: it was reported that "the vizadiscs pop off the array when impacting the cup.This has occurred previously and were placed back on to finish cases.Dr (b)(6) asked that i have the array replaced now that is has reoccurred." the event was confirmed.Method & results: device evaluation and results: visual inspection: the array showed signs of wear.See attached image.Functional inspection: the device is non-functional.Product history review: review of the device history records indicate 30 devices were manufactured and accepted into final stock on 11-10-2011 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot 19050811 shows 0 additional complaints related to the failure in this investigation.Conclusion: the investigation concluded that alleged failure mode was caused by wear.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication or evidence available at this time to suggest that there was a product non-conformity or unanticipated hazard.Should additional information become available the investigation will be reopened and re-evaluated.
Event or Problem Description
The vizadiscs pop off the array when impacting the cup.This has occurred previously and were placed back on to finish cases.Dr (b)(6) asked that i have the array replaced now that is has reoccurred.Case type: tha.

• Brand Name: PELVIC ARRAY ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8858167
• Report Number: 3005985723-2019-00548
• Device Sequence Number: 2716987
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 112230
• Device Lot Number: 19050811
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization