MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111758
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
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
Magnet under level on 2.5 pka end effector fell out during procedure.Unable to use lever and switch to foot pedal for remainder of the case.Case type: pka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections.Reported event: it was reported that the magnet under level on 2.5 pka end effector fell out during procedure.Unable to use lever and switch to foot pedal for remainder of the case.Product inspection: visual inspection: the device was found to be missing the magnet in the switch.Figure showing the failure is attached.Functional inspection: functional inspection was not performed because the magnet was missing.Dimensional inspection: dimensional inspection was not completed as visual inspection clearly shows the failure of the device.Material analysis: not performed as no material failure is alleged.Product history review: review of the device history records indicate 23 devices were manufactured and accepted into final stock on 06/24/2016 with no reported discrepancies.Complaint history review: review of complaints within the trackwise database for p/n: 111758, l/n: 19340515 shows 05 other complaints related to the device failure.Complaint investigation(s) pr: 1255632, 1268420, 1398597, 1525592, 2045945.Nc/capa history review: a review of stryker¿s nc/capa database indicated that nc 1454143 and capa 1454425 are associated with the failure mode reported in this event.Conclusion: the device was found without the magnet to activate the trigger.The failure mode in this investigation 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
Magnet under level on 2.5 pka end effector fell out during procedure.Unable to use lever and switch to foot pedal for remainder of the case.Case type: pka.

• Brand Name: MAKOPLASTY® PARTIAL KNEE END EFFECTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8760051
• Report Number: 3005985723-2019-00492
• Device Sequence Number: 16714437
• Product Code: OLO
• UDI-Device Identifier: 00848486017354
• UDI-Public: 00848486017354
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/01/2019

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: 111758
• Device Lot Number: 1901054
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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