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

Model Number	112227
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
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
During surgery, the robot had to be re-registered prior to cuts being made.After re- registration occurred, the robot passed the check point and we proceeded to cuts.While the surgeon was making the distal femoral cut, the robot kept cutting out, and then made a deeper cut than planned.The surgeon abandoned using the robot and switched to manual.Upon investigation, it was noticed that the tab that locks the base array in place had broken off and the base array was spinning in the mount.See pictures.Case type: tka.Surgery was not completed robotically.
Event or Problem Description
During surgery, the robot had to be re-registered prior to cuts being made.After re- registration occurred, the robot passed the check point and we proceeded to cuts.While the surgeon was making the distal femoral cut, the robot kept cutting out, and then made a deeper cut than planned.The surgeon abandoned using the robot and switched to manual.Upon investigation, it was noticed that the tab that locks the base array in place had broken off and the base array was spinning in the mount.See pictures.Case type: tka surgery was not completed robotically.
Additional Manufacturer Narrative
During surgery, the robot had to be re-registered prior to cuts being made.After re-registration occurred, the robot passed the check point and we proceeded to cuts.While the surgeon was making the distal femoral cut, the robot kept cutting out, and then made a deeper cut than planned.The surgeon abandoned using the robot and switched to manual.Upon investigation, it was noticed that the tab that locks the base array in place had broken off and the base array was spinning in the mount.See pictures.Case type: tka surgery was not completed robotically.Product evaluation and results: visual inspection shows the locking pin on the rio base array is broken.See attached image.Product history review: review of the device history records indicate: 50 devices were manufactured and accepted into final stock on (b)(6) 2018.46 devices were manufactured and accepted into final stock on 05/02/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n (b)(6), lot number 19310118 shows two 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: 9528267
• Report Number: 3005985723-2019-00922
• Device Sequence Number: 16820055
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/27/2020

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 Model Number: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 19310118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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
• Patient Age: 69 YR