MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
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
When impacting the cup on the final hit.The end strike plate broke into pieces and snapped the end off the offset cup impactor.Case type: tha.
Additional Manufacturer Narrative
Product identification: the returned device was confirmed to be a trident inline offset impactor, p/n 209830, l/n 32953, rm 267706.Inspection: visual inspection showed the device's shaft broken where the impaction platform assembles.See the attached figure.Product history: review of device history records shows the following number of devices on their given dates were accepted into final stock with no reported discrepancies: (b)(4) on 03/17/2016, (b)(4) on 01/14/2016, (b)(4) on 01/14/2016, (b)(4) on 02/10/2016, (b)(4) on 02/11/2016.The one rejected device was dispositioned per qt16-01-0036 for an out of spec feature unrelated to the failure in this investigation.Complaint history review: review of complaints within the trackwise database for p/n 209830, l/n 32953 shows zero (0) complaints related to the failure in this investigation.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.Conclusion: functional inspection confirms alleged failure of a broken device.
Event or Problem Description
When impacting the cup on the final hit.The end strike plate broke into pieces and snapped the end off the offset cup impactor case type: tha.

• Brand Name: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8311636
• Report Number: 3005985723-2019-00109
• Device Sequence Number: 1973445
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• 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): 05/30/2019

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: 209830
• Device Lot Number: 32953
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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