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

Catalog Number	112227
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
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
Upon beginning of cutting sequence, saw and femoral checkpoint both passed, advanced to femoral distal cut and lateral femur cut was fine and then saw began to drift off bone and did not make a medial distal cut.Verified that both tibial and femoral arrays were still accurate.Re-registered mako robot and went back to cutting page, both robot and femoral checkpoints passed and continued onto recutting distal femur.Again, saw drifted.Checked base array and it was lose and was missing a prong that locks it in.Exchanged for another one re-registered robot and continued to cut distal femur.Completed surgery successfully.Case type: tka.Surgical delay: 10 minutes.
Event or Problem Description
Upon beginning of cutting sequence, saw and femoral checkpoint both passed, advanced to femoral distal cut and lateral femur cut was fine and then saw began to drift off bone and did not make a medial distal cut.Verified that both tibial and femoral arrays were still accurate.Re-registered mako robot and went back to cutting page, both robot and femoral checkpoints passed and continued onto recutting distal femur.Again, saw drifted.Checked base array and it was lose and was missing a prong that locks it in.Exchanged for another one re-registered robot and continued to cut distal femur.Completed surgery successfully.Case type: tka.Surgical delay: 10 minutes.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted based on the results of investigation.Reported event: upon beginning of cutting sequence, saw and femoral checkpoint both passed, advanced to femoral distal cut and lateral femur cut was fine and then saw began to drift off bone and did not make a medial distal cut.Verified that both tibial and femoral arrays were still accurate.Re-registered mako robot and went back to cutting page, both robot and femoral checkpoints passed and continued onto recutting distal femur.Again, saw drifted.Checked base array and it was lose and was missing a prong that locks it in.Exchanged for another one re-registered robot and continued to cut distal femur.Completed surgery successfully.Product evaluation and results: visual inspection: one of the base array pins is broken off.Functional inspection: functional inspection was not conducted since defect was a visual failure.Dimensional inspection: dimensional inspection was not conducted since defect was a visual failure.Product history review: review of the device history records indicate (b)(4) devices were manufactured under lot 19050116 and accepted into final stock on 11/29/16.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112227, lot number 19050116 shows 04 additional complaints related to the failure in this investigation.These complaints are: pr 1574467, 1617915, 1919076, 1964956.Conclusions: the defect was confirmed as alleged.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.

• 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: 8898803
• Report Number: 3005985723-2019-00596
• Device Sequence Number: 16215667
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/09/2019

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: 112227
• Device Lot Number: 19050116
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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