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

Catalog Number	111758
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
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
Pka end effector handpiece does not work.The magnet was missing from the trigger.
Additional Manufacturer Narrative
Reported event: it was reported that the end effector was non- functional.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the device history records indicate 20 devices were manufactured and accepted into final stock on 12/17/2015 with no reported discrepancies.Complaint history review: review of complaints within the trackwise database for p/n 111758, l/n 19220315 show three 4 other complaints related to the reported failure.The pr's are (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.If additional information is received the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc 1454143 and capa 1454425 h3 other text : device not returned.
Event or Problem Description
Pka end effector handpiece does not work.The magnet was missing from the trigger.

• 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: 7598370
• Report Number: 3005985723-2018-00360
• Device Sequence Number: 179312
• Product Code: OLO
• UDI-Device Identifier: 00848486017354
• UDI-Public: 00848486017354
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/11/2018

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: 19460615
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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