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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 212480
Device Problems Mechanical Problem (1384); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2018
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
Stryker rep reported that the part failed during surgery. Tka was completed using traditional instrumentation. Surgical delay 50 minutes. Update: mr (b)(6) undertook his first ever tka earlier today. The case was going to plan until they were preparing to execute bone resections with the mako. When engaging power on the mics handpiece there was a quiet sound coming from the mics handpiece rather than the usual loud saw noise. Mako specialist troubleshot the mics and also the offset saw attachment (212480). Specialist tried the straight saw attachment, and this functioned properly. Then tried a new mics power tool with the suspect offset saw and again this failed. Due to hospital factors the second attachment kit was unavailable so the decision was made to convert to a manual (depuy pfc) knee replacement. This saw attachment has only ever been used once before. Not aware of any follow up intervention or adverse patient outcomes.
 
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Brand Name2.7 DEGREE ANGLED SAGITAL SAW
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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8205126
MDR Text Key131926228
Report Number3005985723-2018-00802
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number212480
Device Lot Number3503178/35060118
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 Received05/28/2019
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: 12/28/2018 Patient Sequence Number: 1
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