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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. ANSPACH LONG-HD ATTACHMENT STEREOTAXIC DEVICE, INSTRUMENT Back to Search Results
Catalog Number 110920
Device Problems Smoking (1585); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  Malfunction  
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 performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio). During the case, the burr motor became very hot and began smoking. There was no serious consequence to the surgeon or the patient and the case was completed successfully.

 
Manufacturer Narrative

The reported device was confirmed to be an anspach hd long attachment, catalog #: 110920, serial #: (b)(4). Review of the device history records found that 80 devices were inspected and released into inventory on 3/12/2015. A review of photos provided by the complainant clearly shows that the attachment overheated near the distal tip of the shaft. A review of complaints for part number (b)(4), lot number j08310355601 found no other complaint related to the failure in this investigation. Tracking of complaints related to the (b)(4) part number will be tracked through quarterly trend request #866. The device was disposed of by the customer. No inspection could be completed. No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard. The device was disposed of by the customer and therefore was not returned for evaluation.

 
Event Description

The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio). During the case, the burr motor became very hot and began smoking. There was no serious consequence to the surgeon or the patient and the case was completed successfully.

 
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Brand NameANSPACH LONG-HD ATTACHMENT
Type of DeviceSTEREOTAXIC DEVICE, 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
liza gordillo
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key5989416
MDR Text Key55995844
Report Number3005985723-2016-00304
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number110920
Device LOT NumberJ08310355601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated By Manufacturer? No
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: 09/30/2016 Patient Sequence Number: 1
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