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

Catalog Number	206270
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
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
We had an impaction platform shatter upon cup impaction today.Case type: tka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.It was reported that an impaction platform shatter upon cup impaction today.Product evaluation and results: visual inspection from the attached figures confirms the broken / fractured device.Product history review: review of the device history records indicate 29 devices were manufactured and 0 were accepted into final stock on 11/13/2015.Review of qt-15-11-0040 revealed that the non conformance is not related to the failure alleged in this complaint and the 29 devices were accepted were accepted into final stock on 12/15/2015.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 206270, lot: 45011115 shows 3 additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed via the visual inspection of images provided in the communication log.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
We had an impaction platform shatter upon cup impaction today.Case type: tka.

• 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: 8795204
• Report Number: 3005985723-2019-00512
• Device Sequence Number: 11185049
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• 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): 12/10/2019

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?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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