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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 110920
Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2017
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
The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.
 
Manufacturer Narrative
Reported event: the event reported that an anspach hd long attachment loud noise during burring and overheating occurred burning the surgeon's finger. A delay of 10 minutes occurred. Device evaluation and results: the anspach hd long attachment was bench evaluated using a known good anspach motor, anspach foot switch, burr tool and anspach console and all testing successful and the error could not be duplicated. No overheating or audible noise occurred. Device history review: not performed as the anspach hd long attachment is an oem product. Complaint history review: review of complaints for p/n 110920, s/n (b)(4) showed no other complaints within the trackwise database. Conclusion: the failure could not be duplicated. The overheating of the hd long attachment could be due to the anspach motor overheating and transferring thermal energy to the hd long attachment. Corrective action / preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
 
Event Description
The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.
 
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Brand NameANSPACH HD LONG ATTACHMENT
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
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
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6522055
MDR Text Key73694035
Report Number3005985723-2017-00195
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110920
Device Lot NumberSNF44307062101
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2017
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 Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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