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 Code	Tissue Damage (2104)
Date of Event	11/05/2019
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
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 or Problem 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.
Additional 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)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9394852
• Report Number: 3005985723-2019-00865
• Device Sequence Number: 19521026
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• 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: 11/05/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: Other
• Patient Age: 61 YR