MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL BASEPLATE STD RM/LL SIZE 2; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 170612

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that after unsealing the package, the package was found to be empty (no device).

Manufacturer Narrative

An event regarding missing instrument from packaging involving a mck baseplate trial was reported.The event was confirmed by packaging inspection.Method & results: product evaluation and results: visual inspection found that there was a seal on the front of the package however, there was a partial seal on the back of the package.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the package was not properly sealed.An nc was opened to further investigate the issue.The missing product is a trial component that would not be implanted into the patient and is only used intra-operatively to verify implant size options.The kit in which this trial would reside is assembled prior to hospital consignment.Furthermore, it would be confirmed missing from the kit/trialing tray prior to surgery due to an initial assembly and secondary, prior to surgery during sterilization at the hospital.Therefore, intended use is not impacted nor is the labeling impacted as it is a sub-component that could be placed and assembled into a baseplate trial tray.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that after unsealing the package, the package was found to be empty (no device).

• Brand Name: TIBIAL BASEPLATE STD RM/LL SIZE 2
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8026393
• MDR Text Key: 125796062
• Report Number: 3005985723-2018-00642
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003715
• UDI-Public: 00848486003715
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Catalogue Number: 170612
• Device Lot Number: 26090816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other