MAUDE Adverse Event Report: MAKO SURGICAL CORP. LEG POSITIONER TRAY KIT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 151150

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

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

Event Date 04/05/2019

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 long t-bar of the leg positioner has flakes of the black carbon fiber flaking off - i have photos.Case type: tka.

Manufacturer Narrative

Reported event: -customer reported that the long t-bar of the leg positioner has flakes of the black carbonfiber flaking off.Device evaluation and results: -device evaluation was not performed and the leg positioner tray kit event was not confirmed.Device history review: -no product history review could be completed.The pn and lot provided by the customer are for the entire leg holder (and its attachment) kit and not a single component.After multiple attempts to reach the customer for further explanation, no information was retrieved.Complaint history review: -no complaint history review could be completed due to missing information.Conclusions: -no product inspection could be completed due to the product not being returned.Per d03391, preventive maintenance identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.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 long t-bar of the leg positioner has flakes of the black carbon fiber flaking off - i have photos.Case type: tka.

• Brand Name: LEG POSITIONER TRAY KIT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8540368
• MDR Text Key: 142777981
• Report Number: 3005985723-2019-00311
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151150
• Device Lot Number: 3401994
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization