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

Catalog Number	206270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
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 end of the mako straight cup impactor broke off inside of the impaction platform.Case type: tha.Update: "yes the impactor broke during impaction".
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 end of the mako straight cup impactor broke off inside of the impaction platform.Product evaluation and results: as per attached picture the failure mode was confirmed as the provided picture shows that the end of straight shell impactor broke during impaction.Product history review: review of the device history records indicate 39 devices were manufactured under lot dm010812 and 25 devices were accepted into final stock on 09/27/12 and remaining 14 devices were rejected and put in npr 12 - 09 - 0026 on 09/14/12.Review of npr 12 - 09 - 0026 revealed that 10 devices were dispositoned as "use as is" and accepted into final stock on 01/09/2013 and remaining 03 devices were rtv for rework.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206270, lot number dm010812, shows 01 additional complaints related to the failure in this investigation.Complaint id:1510341.Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
The end of the mako straight cup impactor broke off inside of the impaction platform.Case type: tha update: "yes the impactor broke during impaction".

• 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: 8657972
• Report Number: 3005985723-2019-00397
• Device Sequence Number: 2566998
• Product Code: OLO
• UDI-Device Identifier: 00848486022082
• UDI-Public: 00848486022082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/24/2019

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: DM010812
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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