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

Model Number	111645
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Checkpoints left in patient.Patient needed secondary surgery to remove checkpoints, and perform liner exchange.
Event or Problem 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.
Additional 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)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 12335839
• Report Number: 3005985723-2021-00143
• Device Sequence Number: 20078822
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 111645
• Device Catalogue Number: 111645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention