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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 111758
Device Problems Output Problem (3005); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2019
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
The burr did not engage when the surgeon pressed the trigger on the anspach.I reset the cutter and no power to the anspach.I reset the arm software and no power to the anspach.I changed the anspach and ran a burr status check with the trigger and the foot pedal and failed both.I did a hard shut down, re-homed the robot, did another burr status check.I fail both the trigger and foot pedal.I finally swapped out the end effector and ran another burr status check, homed the robot and passed the burr status check.We successfully completed the case.Case type: pka surgical delay: 20-30 minutes.
 
Event Description
The burr did not engage when the surgeon pressed the trigger on the anspach.I reset the cutter and no power to the anspach.I reset the arm software and no power to the anspach.I changed the anspach and ran a burr status check with the trigger and the foot pedal and failed both.I did a hard shut down, re-homed the robot, did another burr status check.I fail both the trigger and foot pedal.I finally swapped out the end effector and ran another burr status check, homed the robot and passed the burr status check.We successfully completed the case.Case type: pka.Surgical delay: 20-30 minutes.
 
Manufacturer Narrative
Reported event: it was reported that the burr did not engage when the surgeon pressed the trigger on the anspach.The cutter was reset and anspach had no power.The arm software was reset and anspach had no power.The anspach was changed and a burr status check was run with the trigger and the foot pedal and both failed.A hard shut down was completed, the robot was re-homed and another burr status check completed.Both the trigger and foot peda failed.The end effector was then swapped out and ran another burr status check, homed the robot and passed the burr status check.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review review of the product history records indicate (b)(4) devices were manufactured under lot number 19140217 and (b)(4) devices were accepted into final stock on 08/29/2017.Review of qt17 - 08 - 0084 revealed that 01 device was rejected for document error.This device was accepted into final stock when documents were received.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 111758, lot number 19140217 shows 01 additional complaints related to the failure in this investigation.Complaint investigation(s) pr: (b)(4).Conclusions: 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 ncs or capas 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
MAKOPLASTY® PARTIAL KNEE END EFFECTOR
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8720754
MDR Text Key155703454
Report Number3005985723-2019-00446
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486017354
UDI-Public00848486017354
Combination Product (y/n)N
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number111758
Device Lot Number1902609
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/10/2019
Initial Date FDA Received06/20/2019
Supplement Dates Manufacturer Received10/18/2019
Supplement Dates FDA Received10/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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