MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMP DEMAYO KNEE POSITIONER - 25 KIT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110570

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

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

The blue track was not securing the boot very well.Leg kept falling when not being held.Pka.

Manufacturer Narrative

Reported event: customer reported that the blue track was not securing the boot very well.Device evaluation and results: device evaluation was not performed due to the part not being returned.Device history review: not performed as the imp demayo knee positioner - 25 kit is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the imp demayo knee positioner - 25 kit.There have been no other events for the referenced part number that can be confirmed.Conclusions: no product inspection could be completed due to the product not being returned.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

Event Description

The blue track was not securing the boot very well.Leg kept falling when not being held.Pka.

• Brand Name: IMP DEMAYO KNEE POSITIONER - 25 KIT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8193244
• MDR Text Key: 131308718
• Report Number: 3005985723-2018-00770
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110570
• Device Lot Number: 803S-0391MB BLUE LEG TRACK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization