MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL ARRAY; STEREOTAXIC DEVICE, ROBOTICSM

Catalog Number	112210
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
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
Femoral array flickered in and out throughout case; vizadiscs were swapped multiple times; burr would not start.Once array was swapped, case continued.Surgical delay: 16-30 minutes.Case type: pka.
Additional Manufacturer Narrative
Reported event: it was reported that femoral array flickered in and out throughout case; vizadiscs were swapped multiple times; burr would not start.Once array was swapped, case continued.Product evaluation and results: product inspection could not be performed as the product was lost and not available for evaluation.Product history review: review of the device history records indicate 25 devices were manufactured and accepted into final stock on 03/29/11.No non-conformances were identified during inspection.Complaint history review: a review of complaints in trackwise related to p/n 112210, lot number 06130211 shows 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.Device not returned.
Event or Problem Description
Femoral array flickered in and out throughout case; vizadiscs were swapped multiple times; burr would not start.Once array was swapped, case continued.Surgical delay 16-30 minutes.Case type: pka.

• Brand Name: FEMORAL ARRAY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICSM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8034415
• Report Number: 3005985723-2018-00649
• Device Sequence Number: 1262455
• Product Code: OLO
• UDI-Device Identifier: 00848486002909
• UDI-Public: 00848486002909
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• 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): 01/14/2019

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: 112210
• Device Lot Number: 06130211
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/14/2019
• 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