MAUDE Adverse Event Report: MAKO SURGICAL CORP. SHELL IMPACTION PLATFORM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	206270
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
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
Broke during impaction.Case type: tha.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that the impaction plate broke during impaction product evaluation and results: visual inspection: visual inspection showed the impaction platform broken into two separate pieces.Please see attachment.Functional inspection, dimensional inspection and material analysis were not completed as visual inspection confirmed the failure.Product history review: review of the device history records indicate 29 devices were manufactured under lot 45011115 and 29 devices were rejected for missing documentation on 11/13/2015.The missing documentation was supplied as part of qt-15-11-0040 and all 29 devices were accepted into final stock on 12/15/2015.Complaint history review: review of complaints for p/n 206270, l/n 45011115 within the trackwise database show 02 other complaints related to the failure in this investigation.Complaint investigation(s) pr: 1559082, 1803573 conclusions: visual inspection showed the impaction platform broken into two separate pieces.Failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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
Broke during impaction.Case type: tha.

• Brand Name: SHELL IMPACTION PLATFORM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8736797
• Report Number: 3005985723-2019-00466
• Device Sequence Number: 19492274
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• 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): 09/04/2019

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: 206270
• Device Lot Number: 45011115
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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