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

Model Number 209063

Device Problems Output Problem (3005); Insufficient Information (3190)

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

Event Date 10/09/2019

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

(b)(4) - mps (b)(6) reported stabilize tibia moving too fast error on first cut.Performed mics status check which passed.Shutdown, cleaned cables, swapped mics hand pieces, rehomed, mics status check passed.Reentered case and got no power to the mics.Mps swapped robots to complete case.Case number: (b)(4).Case type: tka.Update: surgical delay "25 min.".

Event Description

Rob440 - mps nathan chandler reported stabilize tibia moving too fast error on first cut.Performed mics status check which passed.Shutdown, cleaned cables, swapped mics hand pieces, rehomed, mics status check passed.Reentered case and got no power to the mics.Mps swapped robots to complete case.Case number: (b)(4).Case type: tka.Update: surgical delay "25 min".

Manufacturer Narrative

Rob440 - mps nathan chandler reported stabilize tibia moving too fast error on first cut.Performed mics status check which passed.Shutdown, cleaned cables, swapped mics hand pieces, rehomed, mics status check passed.Reentered case and got no power to the mics.Mps swapped robots to complete case.Case number: (b)(4).Case type: tka.Update: surgical delay "25 min".Product inspection.The product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Device history review.Review of the product history records indicate (b)(4) devices were manufactured under lot no k0b1b and accepted into final stock on 04/17/2018.No non-conformances were identified during inspection.Complaint history review.A review of complaints in catsweb and trackwise related to p/n 209063, lot number 42060318 shows 06 additional complaints related to the failure in this investigation.Conclusion.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.

• 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: 9233099
• MDR Text Key: 177795775
• Report Number: 3005985723-2019-00756
• 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: 02/26/2020

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 Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42060318
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization