MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN TRIAL; KNEE INSTRUMENT

Catalog Number UNK_OFL

Device Problem Positioning Problem (3009)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.Should additional information become available, a supplemental report will be submitted.Device not returned.

Event Description

Mako pka right medial case: during trialing of the femoral component (size 5 rm) it was indicated by the surgeon that the femoral trial was not sitting as it should based on the virtual plan and the resected area in that it was approximately 6-8mm posterior from the anterior tip.The femoral trial size was confirmed and i then reconfirmed that the checkpoints, arrays, bone registration were still valid and that the burred area was as per the plan to which everything seemed accurate.Another size 5 rm trial from another kit was then used to compare, to which there was approx 3mm of difference between the two components, however, neither fitted the burred area as they should.A size 6 trial was then used which fitted the resected area better.The plan on the computer was then changed to a size 6 and re-burred the femur to accommodate and was executed adequately for that plan.As we had to go up a size based on the original plan it resulted in the joint being slightly tighter and as such not as what the surgeon wanted originally.

• Brand Name: UNKNOWN TRIAL
• Type of Device: KNEE INSTRUMENT
• 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: racquel aking ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6433721
• MDR Text Key: 70873378
• Report Number: 3005985723-2017-00141
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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