MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	112227
Medical Device Problem Codes	Difficult to Insert (1316); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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
Blue probe- failed probe check at 1.5mm.Base array- base array post was stiff and difficult to compress, there seemed to be sticky residue on the post and after cleaning it still was difficult to properly attach to the robot.Surgical delay: = 15 minutes.Case type / application: tka.
Additional Manufacturer Narrative
Reported event.An event regarding mechanical failure involving a mako arrays was reported.The event was confirmed.Method & results.-product evaluation and results: functional inspection confirms the rio base aray post has seized and has difficulty moving.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Blue probe- failed probe check at 1.5mm.Base array- base array post was stiff and difficult to compress, there seemed to be sticky residue on the post and after cleaning it still was difficult to properly attach to the robot.Surgical delay: = 15 minutes.Case type / application: tka.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 12160959
• Report Number: 3005985723-2021-00130
• Device Sequence Number: 19987476
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/03/2021

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 Model Number: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 19410418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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: Other