MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170704-1

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2016

Event Type  malfunction  

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 Description

When the surgeon was removing the tibia trial component, a small piece of green material broke off from the holes on the anterior edge of the trial insert.

Manufacturer Narrative

An event regarding crack/fracture involving a tibial insert onlay trial ¿ size 4 - 8 mm was reported.The event was confirmed.Method & results: device evaluation and results: there are scratches on various areas of the trial.One side of the trials holes has a small piece fractured.Examination of the returned device with material analysis engineer noted the fracture occurred due to an overload condition as indicated by hackles observed on the fracture surface.Additionally, explantation damage observed on the trial.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been 1 other event for the lot referenced.Conclusions: the investigation concluded that the removal of the tibial trial caused the trial to fracture from the holes.It was determined by an examination by an mar engineer that the fracture occurred due to an overload condition as indicated by hackles observed on the fractured service.There was also explantation damage observed on the trail.

Event Description

When the surgeon was removing the tibia trial component, a small piece of green material broke off from the holes on the anterior edge of the trial insert.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6074227
• MDR Text Key: 59049954
• Report Number: 3005985723-2016-00353
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2017
• Device Catalogue Number: 170704-1
• Device Lot Number: LOT#1222011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other