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

Model Number 210080

Device Problem Material Frayed (1262)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2019

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

The leg holder is fraying and catching on things around the edges on the calf area.Case type: no associated procedure.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11.Based on the results of investigatio n.Reported event: the leg holder is fraying and catching on things around the edges on the calf area.Product evaluation and results: visual confirmatio n confirms the boot assembly has carbon fiber splinters.See attached image.Product history review: review of the device history records indicate 100 devices were manufactured and accepted into final stock on 06- 05-2018 with no reported discrepanci es.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210098, l/n 2018430420 09 shows 3 additional complaints related to the failure in this investigatio n.Pr id :(b)(4).Conclusions : per d03391, preventive maintenanc e is where an action occurs that identifies device deterioratio n which may compromis e function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure mode was confirmed as alleged via visual inspection.If additional information is received then the complaint will be reopened.Corrective action/prev entive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

Event Description

The leg holder is fraying and catching on things around the edges on the calf area.Case type: no associated procedure.

• 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: 9396896
• MDR Text Key: 189676130
• Report Number: 3005985723-2019-00882
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201843042009
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization