MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210060
Medical Device Problem Codes	Material Deformation (2976); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
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
Gauges on side of leg holder base bar- can you please ship overnight? case type: no associated procedure.
Additional Manufacturer Narrative
Reported event: it was reported that gauges on side of leg holder base bar.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 25 devices were manufactured and accepted into final stock on (b)(6) 2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210060, lot 594362 shows 0 additional complaints related to the failure in this investigation.Conclusions: per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.
Event or Problem Description
Gauges on side of leg holder base bar- can you please ship overnight? case type: no associated procedure.

• Brand Name: BASE BAR ASSM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8864787
• Report Number: 3005985723-2019-00558
• Device Sequence Number: 2070626
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 09/29/2019

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: 210060
• Device Lot Number: 594362
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/29/2019
• 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