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 Problem Tissue Damage (2104)

Event Date 11/05/2019

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

It was reported that after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the (b)(6) surgery was not present for either procedure, but two mps's were present for the (b)(6) procedure.Rep reported that no further information will be released by the hospital or surgeon.

Event Description

It was reported that after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the november surgery was not present for either procedure, but two mps's were present for the october procedure.Rep reported that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: it was reported that after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the november surgery was not present for either procedure, but two mps's were present for the october procedure.Rep reported that no further information will be released by the hospital or surgeon.Product evaluation and results: product inspection was not performed as product was not available for inspection.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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• 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: 9394852
• MDR Text Key: 168599666
• Report Number: 3005985723-2019-00865
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 111645
• Device Catalogue Number: 111645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR