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

Model Number 210080

Device Problems Material Frayed (1262); Sharp Edges (4013)

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

Event Date 02/28/2020

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

Fraying and sharp edges on boot.Surgeon worried about cutting patient.Patient was not cut.No harm was done.Case type: tka.

Event Description

Fraying and sharp edges on boot.Surgeon worried about cutting patient.Patient was not cut.No harm was done.Case type: tka.

Manufacturer Narrative

Reported issue: fraying and sharp edges on boot.Surgeon worried about cutting patient.Patient was not cut.No harm was done.Case type: tka.Product inspection: visual inspection shows the boot assembly has splintering along the edges.See attached image for visual confirmation of the failure.Product history review: a review of the product history records indicates that 98 devices were manufactured under catalog #210080 lot no 201743102701, and all were accepted into final stock on 10/30/2017.There were no non-conformity identified during inspection.A review of the product history records indicates that (b)(4) devices were manufactured under catalog #210080 lot no 201743102701, and all were accepted into final stock on 04/24/2018.There were no non-conformity identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot number 201743102701 shows one additional complaint related to the failure in this investigation: (b)(4).Conclusion: 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 failure was confirmed as alleged via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive 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.

• 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: 9876713
• MDR Text Key: 184825540
• Report Number: 3005985723-2020-00173
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 201743102701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization