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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ACCESSORY
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MAKO SURGICAL CORP. MAKOPLASTY PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ACCESSORY Back to Search Results
Catalog Number 111770
Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2015
Event Type  malfunction  
Event Description
A surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Prior to the case, the surgical staff noticed that the o-ring was missing from the end effector.The second end effector selected did not work properly during the case and a third end effector was used to complete the case.The case was successfully completed and there was no harm to the patient.
 
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.A supplemental report will be filed when additional information is obtained.
 
Manufacturer Narrative
Reported event: during initial setup prior to the patient being in the room, the o-ring on the end effector was seen to be missing.A backup instrument was used and there was no impact to the case.Device evaluation and results: visual inspection: visual inspection shows the presence of the orange o-ring which was alleged to be missing from the end effector.(b)(4).Dimensional inspection: dimensional inspection was not completed as the alleged failure was not related to any dimensional characteristics.Functional inspection: functional inspection shows the end effector mates properly with the anspach motor.The o-ring does not prevent the anspach from assembling into the end effector properly.Device history review: review of the device history records indicate 21 devices were manufactured and accepted into final stock on 03/23/2011.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111770, s/n (b)(4) shows no complaints related to the failure in this investigation.Tracking of complaints related to the 111770 part number will be tracked through quarterly trend request #740.Conclusions: the end effector is fully functional.
 
Event Description
A surgeon performed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.Prior to the case, the surgical staff noticed that the o-ring was missing from the end effector.The second end effector selected did not work properly during the case and a third end effector was used to complete the case.The case was successfully completed and there was no harm to the patient.
 
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Brand Name
MAKOPLASTY PARTIAL KNEE END EFFECTOR
Type of Device
STEREOTAXIC DEVICE, ACCESSORY
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
jonathan reeves
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key4778571
MDR Text Key16457688
Report Number3005985723-2015-00076
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number111770
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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