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

Catalog Number	209830
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
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
While dr.(b)(6) was using a mallet to impact the trident cup into the patient the impaction platform piece cracked down the center and eventual broke in half once we removed it from the inline-offset impaction handle.Case type: tha.
Event or Problem Description
While dr.(b)(6) was using a mallet to impact the trident cup into the patient the impaction platform piece cracked down the center and eventually broke in half once we removed it from the inline-offset impaction handle.Case type: tha.
Additional Manufacturer Narrative
Reported event: it was reported that while dr.(b)(6) was using a mallet to impact the trident cup into the patient the impaction platform piece cracked down the center and eventually broke in half once we removed it from the inline-offset impaction handle.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the device history records indicate 88 devices were manufactured under lot 33850.26 devices were accepted into final stock on 11/01/2016.01 devices were accepted into final stock on 11/30/2016.60 devices were accepted into final stock on 08/18/2016.Review of qt16 - 08 - 0065 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 209830, l/n 33850 show no additional complaint related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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.Product was not available for evaluation.

• 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: 8200171
• Report Number: 3005985723-2018-00786
• Device Sequence Number: 16452438
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/25/2019

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: 33850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/25/2019
• 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