MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number	180737-1
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.
Event or Problem Description
As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device indicates there are a number of scratches on the surfaces of the device consistent with attempted implantation and explantation damage.Material analysis: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all 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 reported lot.Conclusion: one insert was returned for evaluation.There are scratches on the surfaces of the insert consistent with attempted implantation and explantation damage.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7780539
• Report Number: 3005985723-2018-00485
• Device Sequence Number: 13782759
• Product Code: NPJ
• UDI-Device Identifier: 00848486016647
• UDI-Public: 00848486016647
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 180737-1
• Device Lot Number: 9H75XE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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: Other
• Patient Age: 67 YR