MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN ROBOT PKA 3.0; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

As part of 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

User feedback reported "during a lateral (size 1) partial knee procedure with version 3.0 software, doctor stated that burr damaged the it band and fat pad while burring the tibia." case type: not reported.

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving an unknown pka software was reported.The event was not confirmed.Method & results product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the alleged failure mode was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the log/session files, the primary operative report as well as follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

User feedback reported "during a lateral (size 1) partial knee procedure with version 3.0 software, doctor stated that burr damaged the it band and fat pad while burring the tibia" case type : not reported.

• Brand Name: UNKNOWN ROBOT PKA 3.0
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10838521
• MDR Text Key: 216365707
• Report Number: 3005985723-2020-00359
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other