MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209830

Device Problem Break (1069)

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

Event Date 11/26/2018

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

Offset impaction handle and impaction platform both broke upon impaction.Case type: tha.Surgical delay- =15 minutes.

Event Description

Offset impaction handle and impaction platform both broke upon impaction.Case type: tha, surgical delay- =15 minutes.

Manufacturer Narrative

It was reported that the impactor broke during the impaction.The product was unavailable for inspection as the product was not returned.Product history review was not provided as the lot number was not provided.Complaint history review was not provided as the lot number was not provided.The failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Product was unavailable for inspection as the product was not returned.

• Brand Name: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8161731
• MDR Text Key: 130319937
• Report Number: 3005985723-2018-00746
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (y/n): N
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization