MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112227
Medical Device Problem Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
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
The robot keep flickering on the screen, and realized the visa disc wasn¿t sitting flush due to a bent prong.Case type: tka.Patient under anesthesia.Surgical delay: 16-30 minutes.
Event or Problem Description
The robot keep flickering on the screen, and realized the visa disc wasn¿t sitting flush due to a bent prong.Case type: tka.Patient under anesthesia.Surgical delay: 16-30 minutes.
Additional Manufacturer Narrative
The robot keep flickering on the screen, and realized the visa disc wasn¿t sitting flush due to a bent prong.Case type: tka.Patient under anesthesia.Surgical delay: 16-30 minutes.Product evaluation and results: functional test confirms the mako array is bent and the vizadisc will not sit flat in the array.Product history review: review of the product history records indicate 76 devices were manufactured under lot no 19420318, and 76 accepted into final stock on (b)(6) 2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112227, lot number 19420318, shows 0 additional complaints related to the failure in this investigation.Conclusions: the event was confirmed.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9191858
• Report Number: 3005985723-2019-00741
• Device Sequence Number: 2550929
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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): 01/06/2020

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: 112227
• Device Lot Number: 19420318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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