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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 112227
Device Problems Break (1069); Non Reproducible Results (4029)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2019
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
It was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.
 
Event Description
It was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.Update: 1.Was case was converted from a pka to a tka based on the event?.Yes.Update: right side.Surgical procedure completed manually.
 
Manufacturer Narrative
Reported event: it was reported by the distributor that the base array was installed by the nurse on the robot.During installation, a noise was heard (one of the pins on the base array may have been broken at that time), but at that point the nurse confirmed that it was stable.Intraoperatively, it was discovered by the surgeon that the base array was moving, which caused inaccuracy in the bone preparation, resulting in over removal of the femur bone which he had to eventually convert to a total knee replacement due to that.Post operatively, it was discovered that a pin from the base array was broken which caused the instability, leading to inaccurate bone removal.Product evaluation and results: visual inspection: visual inspection confirmed broken locking pin.See attachment 1 for image of the instrument.Dimensional inspection: dimensional inspection was not completed since visual inspection and functional inspection confirmed broken locking pin.Functional inspection: functional inspection confirmed broken locking pin would not allow for secure placement of base array during insertion and twisting to engage.Product history review: 1.Review of the device history records indicate 78 devices were manufactured and accepted into final stock on 02-06-2017 with no reported discrepancies.2.Review of the device history records indicate 22 devices were manufactured and accepted into final stock on 02-25-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n (b)(4), lot number 19071016 shows no additional complaints related to the failure in this investigation.Conclusions: per d03391, the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.
 
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Brand Name
ARRAY- RIO BASE
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8573855
MDR Text Key143841366
Report Number3005985723-2019-00332
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486017446
UDI-Public00848486017446
Combination Product (y/n)N
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number112227
Device Lot Number19071016
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/17/2019
Initial Date FDA Received05/02/2019
Supplement Dates Manufacturer Received08/29/2019
Supplement Dates FDA Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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