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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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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 Key12193004
MDR Text Key262462448
Report Number3005985723-2021-00132
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K142530
Number of Events Reported1
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 Number219999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received11/09/2021
Supplement Dates FDA Received12/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age81 YR
Patient SexFemale
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