MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 8; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180608

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Manufacturer Narrative

During a review of complaints in our legacy system, it was determined that (b)(6) cso #(b)(4) required an mdr that was not processed at the time of the investigation.The final report is submitted based on the results of the investigation.This device was packed used the previous packaging (clam shell pack).This pack utilize two mylar/tyvek pouches one inner and one outer.The package had both component seals broken large enough to fit the device through.Actual packaging is not using these components but there is product on the field that could potentially have this condition.(b)(4) was contacted to provide inspection evidence of the parts being within specifications when received.Validation of packaging was performed (b)(4) metal 5yr aging.

Event Description

An implant that was to be used for a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants was deemed unfit for use as there were shavings inside of the package.The implant was not used and a new implant was opened and used.This event did not affect the outcome of the case which was successful.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 8
• 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: jonathan reeves ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 5608090
• MDR Text Key: 43649208
• Report Number: 3005985723-2016-00131
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 180608
• Device Lot Number: 26030211
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005985723-12-28-15-004R
• Patient Sequence Number: 1
• Patient Outcome(s): Other