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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209063
Device Problems Power Problem (3010); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
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
We opened the power to set up the room and the first power (42031116) would not accept the reamer adaptor.We swapped it out with a second power that failed during the surgery.The next day i tested both powers to see if they would accept the reamer adaptor and the one that failed would, but the other would not.So i have one that has no power and another that does not work.=15 minutes surgical delay.
 
Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: we opened the power to set up the room and the first power (42031116) would not accept the reamer adaptor.We swapped it out with a second power that failed during the surgery.The next day i tested both powers to see if they would accept the reamer adaptor and the one that failed would, but the other would not.So i have one that has no power and another that does not work.=15 minutes surgical delay.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Capa 2127499 product history review: device history records indicate 25 devices were manufactured under lot k09gu and 11 devices were inspected and accepted into final stock on 5/31/17.No non-conformances were identified during inspection.14 other devices were inspected and 13 devices were accepted into final stock on 05/10/2017.A review of qt-17-05-0043 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot k09gu shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been nc 1414517 and capa 1450904 associated with the product and failure mode reported in this event.Product was not available for evaluation.
 
Event Description
We opened the power to set up the room and the first power (42031116) would not accept the reamer adaptor.We swapped it out with a second power that failed during the surgery.The next day i tested both powers to see if they would accept the reamer adaptor and the one that failed would, but the other would not.So i have one that has no power and another that does not work.=15 minutes surgical delay.I need replacements for both.Both of the bad ones are ready to ship.Case type: tha.
 
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Brand Name
HANDPIECE MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8211786
MDR Text Key131894338
Report Number3005985723-2019-00016
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030193
UDI-Public00848486030193
Combination Product (y/n)N
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209063
Device Lot Number42050417
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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