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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209830
Device Problems Contamination (1120); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the 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
Cleaning/spd issue with offset impaction handle.Black residue came out when surgeon was trying to screw cup on.Because it contaminated the entire field, the surgeon demanded both handles be removed immediately and are set aside and packaged to be sent back.We will need two offset impaction handles to replace the two we will be sending back.Case type: tha.Surgical delay: 15 minutes.
 
Manufacturer Narrative
Follow-up #1 and final report submitted.Product identification: the returned product was confirmed to be a trident straight cup impactor, p/n 209830, l/n 33850 and rma 267260.Inspection: material analysis showed no biological matter please see attached material analysis report (mar) under the communication log.Product history: review of the device history records indicate 26 devices were manufactured and accepted into final stock on 11/01/2016.No non-conformances were identified during inspection.Complaint history review: review of complaints within the trackwise database for p/n 209830, l/n 33850 show (2) other complaints related to the failure in this investigation.Pr 1729036 pr 1729035.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.Conclusion: functional inspection did not confirm alleged failure of improper cleaning.
 
Event Description
Cleaning/spd issue with offset impaction handle.Black residue came out when surgeon was trying to screw cup on.Because it contaminated the entire field, the surgeon demanded both handles be removed immediately and are set aside and packaged to be sent back.We will need two offset impaction handles to replace the two we will be sending back.Case type: tha.Surgical delay: = 15 minutes.
 
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Brand Name
RIO®SHELL IMPACT-OFFSET-TRIDENT PST
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8351633
MDR Text Key136614064
Report Number3005985723-2019-00147
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030285
UDI-Public00848486030285
Combination Product (y/n)N
PMA/PMN Number
K141989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209830
Device Lot Number33850
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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