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

Model Number 210080

Device Problem Material Frayed (1262)

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

Event Date 01/07/2020

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

During joint assessment of surgery, surgeon noticed that carbon fibers on the boot appeared to be frayed.Frayed area is noticeable at the top portion of the boot near the calf.No adverse consequences.Please replace boot as soon as possible.Case type: tka.

Manufacturer Narrative

Reported issue during joint assessment of surgery, surgeon noticed that carbon fibers on the boot appeared to be frayed.Frayed area is noticeable at the top portion of the boot near the calf.No adverse consequences.Please replace boot as soon as possible.Product inspection: visual inspection confirms the carbon fibers have splintered on the boot assembly.See attached image.Product history review: review of the product history records indicate that under lot no 201843071007: 1.(b)(4) devices were manufactured and accepted into final stock on 07/18/2019.No non-conformances were identified during inspection.2.(b)(4) devices were manufactured and accepted into final stock on 09/10/2019.No non-conformances were identified during inspection.3.(b)(4) devices were manufactured and accepted into final stock on 10/30/2019.No non-conformances were identified during inspection.4.(b)(4) devices were manufactured and accepted into final stock on 11/20/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot number 201843071007, shows 03 additional complaints related to the failure in this investigation.Pr id (b)(4).Conclusion: 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 has been no nc or capa associated with the product and failure mode reported in this event.

Event Description

During joint assessment of surgery, surgeon noticed that carbon fibers on the boot appeared to be frayed.Frayed area is noticeable at the top portion of the boot near the calf.No adverse consequences.Please replace boot as soon as possible.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: 9646676
• MDR Text Key: 176994879
• Report Number: 3005985723-2020-00058
• 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: 03/30/2020

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: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201843071007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization