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

Catalog Number	209830
Medical Device Problem Codes	Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2019
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
During impaction, impaction platform and the back on the inline-offset impaction broke.The platform cracked in half while taking a piece of the back of the impactor.Impaction was still completed with the robot with no patient harm and outcomes were not affected.Case type: tha.Update: "no debris/components were left inside of the patient.No components of the device were missing or disassembled when the issue occurred.".
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 during impaction, impaction platform and the back on the inline-offset impaction broke.The platform cracked in half while taking a piece of the back of the impactor.Impaction was still completed with the robot with no patient harm and outcomes were not effected.Device evaluation and results: product inspection could not be performed as the product was not available for evaluation.Device history review: review of the device history records indicate 35 devices were manufactured under lot 32952 and accepted into final stock on 05/14/2016.No non-conformance were identified during inspection.Complaint history review: a review of complaints related to p/n 209830, l/n 32952 show 03 additional complaint related to the failure in this investigation.The pr's is 1846063, 1868096, 1953961.Conclusion: 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.H3 other text : product was not available for evaluation.
Event or Problem Description
During impaction, impaction platform and the back on the inline-offset impaction broke.The platform cracked in half while taking a piece of the back of the impactor.Impaction was still completed with the robot with no patient harm and outcomes were not effected.Case type: tha.Update: "no debris/components were left inside of the patient.No components of the device were missing or disassembled when the issue occurred.".

• 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: 8642089
• Report Number: 3005985723-2019-00387
• Device Sequence Number: 1654835
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 209830
• Device Lot Number: 32952
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/24/2019
• 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
• Patient Age: 58 YR