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

Catalog Number	112230
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During impaction the vizadisc kept popping off one of the pelvic array pegs that secures the vizadisc.It was determined after the case that the peg that secures the vizadisc was damaged after attempting to put another vizadisc on the array and not being able to keep it secure to the array.Case type: tha.
Additional Manufacturer Narrative
Reported event: during impaction the vizadisc kept popping off one of the pelvic array pegs that secures the vizadisc.It was determined after the case that the peg that secures the vizadisc was damaged after attempting to put another vizadisc on the array and not being able to keep it secure to the array.Case type: tha.Update: no debris/components left in patient.No components of the device missing or disassembled.Product evaluation and results: the reported device was confirmed to be a pelvic array assy, p/n 112230, lot 19170515.Functional test: all metal post are holding known good vizadisc, some wear was found on the posts.Product history review: review of the device history records indicate 50 devices were manufactured and accepted into final stock on 01-22-2016 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19170515 shows zero additional complaint related to the failure in this investigation.Conclusions: the event could not be duplicated, as all metal post are holding known good vizadisc, some wear was found on the posts.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
During impaction the vizadisc kept popping off one of the pelvic array pegs that secures the vizadisc.It was determined after the case that the peg that secures the vizadisc was damaged after attempting to put another vizadisc on the array and not being able to keep it secure to the array.Case type: tha.Update: no debris/components left in patient.No components of the device missing or disassembled.

• 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: 8871208
• Report Number: 3005985723-2019-00576
• Device Sequence Number: 18964253
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 19170515
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 08/07/2019
• 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