MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210080

Device Problem Material Frayed (1262)

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

Event Date 09/18/2019

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

Boot #2 this month.The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.

Manufacturer Narrative

Boot #2 this month.The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.Product evaluation and results: the product was confirmed to be a boot assembly, catalog # 210080 , lot # 201843032009.Visual inspection: confirms the proximal edge of the boot is fraying showing signs of wear.Product history review: review of the device history records indicate 100 devices were manufactured and 100 device accepted into final stock on 06/05/2018.Complaint history review: a review of complaints related to p/n: 110810, lot number: 201843032009, shows 0 additional complaint(s) related to the failure in this investigation.Conclusion: the event was confirmed.

Event Description

Boot #2 this month.The proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9100869
• MDR Text Key: 159442627
• Report Number: 3005985723-2019-00686
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210080
• Device Lot Number: 201843032009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization