MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Model Number 111645

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

As part of the 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

Checkpoints left in patient.Patient needed secondary surgery to remove checkpoints, and perform liner exchange.

Event Description

Checkpoints left in patient.Patient needed secondary surgery to remove checkpoints, and perform liner exchange.Update: the surgeon informed me a few days after the primary surgery that we had left hardware in but if no intervention was necessary, we would leave it.The patient's knee became swollen and infected, so we went back in for a hardware removal and liner exchange.At that point i considered the case to be resolved.

Manufacturer Narrative

The following device was also listed in this report: device: femoral/tibial checkpoint kit -(sterile); catalogue: 111645 ; lot#: unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: checkpoints left in patient.Patient needed secondary surgery to remove checkpoints, and perform liner exchange.Case type / application: tka.Update: the surgeon informed me a few days after the primary surgery that we had left hardware in but if no intervention was necessary, we would leave it.The patient's knee became swollen and infected, so we went back in for a hardware removal and liner exchange.At that point i considered the case to be resolved.Product history review: product history review was not conducted as lot number was not provided.Complaint history review: complaint history review was not conducted as lot number was not provided.Conclusions: the alleged failure is due to the user error, since user has not followed the surgical protocol.There is no issue with the device.If device and/or additional information become available, this investigation will be reopened.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 12335839
• MDR Text Key: 267039795
• Report Number: 3005985723-2021-00143
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 111645
• Device Catalogue Number: 111645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention