MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Output Problem (3005); Complete Loss of Power (4015)

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

Event Date 09/07/2019

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

During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.There was a 20 min delay.Patient's left knee.Primary procedure.

Manufacturer Narrative

During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.The product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.A review of the device history records could not be performed as lot code/serial number information was unknown.A review of the complaint history could not be performed as lot code information was unknown.Per (b)(4), preventive maintenance is where an action occurs that 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.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.A review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is nc (b)(4) and capa 1450904.Device not returned.

Event Description

During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.There was a 20min delay.Patients left knee.Primary procedure.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8975123
• MDR Text Key: 156921578
• Report Number: 3005985723-2019-00655
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization