MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	170505
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The trial femoral component is damaged so don¿t engage the manual impactor tool.
Additional Manufacturer Narrative
Corrected data: d3 - manufacturing entity.An event regarding damage involving a mako trial was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however one photograph was provided for review.The photograph shows some biological material on the device but there is no damage evident medical records received and evaluation: not performed as no medical information was received for review product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as deice return and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The trial femoral component is damaged so don¿t engage the manual impactor tool.

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 5
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8045883
• Report Number: 3005985723-2018-00654
• Device Sequence Number: 1539953
• Product Code: NPJ
• UDI-Device Identifier: 00848486003500
• UDI-Public: 00848486003500
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 170505
• Device Lot Number: 26310912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 03/14/2019
• 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: Other