MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 219999

Device Problems Fracture (1260); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/23/2021

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

It was reported by sale rep that there was an accident in mako tka case at (b)(6) ((b)(6) 2021 ) which surgeons of this case found some fracture of posterior condyle of femur after done in every step of bone cut affected to femur prosthesis which can not place in there.It may be occurred from soft bone or too big housing cutting block for size 2 of femur prosthesis.So they ask for constrain prosthesis with stem to use replaced but we haven't prepare with this case because this is primary case.However surgeons ask for support from zimmer company and the operation was completely done.Surgical delay 2 hours.

Manufacturer Narrative

Reported event an event regarding intraop fracture involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results -product evaluation and results: review of the case session files was not performed as case session data was not provided.It was noted by the software team that they were unable to locate the folder and therefore they were unable to retrieve the files for review.A review of service max did not note any issues.An issue against the software is unclear.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that the robot was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints shows no similar complaints.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays, return of the device and additional information as to why a housing cutting block was utilized are needed to fully investigate the event product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

Event Description

It was reported by sale rep that there was an accident in mako tka case at siph ((b)(6) 2021 ) which surgeons of this case found some fracture of posterior condyle of femur after done in every step of bone cut affected to femur prosthesis which can not place in there.It may be occurred from soft bone or too big housing cutting block for size 2 of femur prosthesis.So they ask for constrain prosthesis with stem to use replaced but we haven¿t prepare with this case because this is primary case.However surgeons ask for support from zimmer company and the operation was completely done.Surgical delay 2 hours.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, FL WD6 3-SJ ; UK WD6 3SJ ; 9546280700
• MDR Report Key: 12193004
• MDR Text Key: 262462448
• Report Number: 3005985723-2021-00132
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female