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

Model Number 210080

Device Problems Crack (1135); Material Frayed (1262)

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

Event Date 01/13/2020

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

Cpd alerted our jr rep about cracking and delamination of the black leg holder.There is concern for further cracking and possible patient/staff harm when in use.Would like to replace the part.Case type: no associated procedure.

Manufacturer Narrative

Reported event: cpd alerted our jr rep about cracking and delamination of the black leg holder.There is concern for further cracking and possible patient/staff harm when in use.Would like to replace the part.Case type: no associated procedure.Product inspection : visual inspection confirms the boot assembly has splintered along the top of the boot.See attached image for confirmation.Product history review; review of the device history records indicate (b)(4) devices were manufactured and (b)(4) device accepted into final stock on 07/06/2018.Additionally (b)(4) device was manufactured and accepted into final stock on 08/10/2018 with no reported discrepancies.Complaint history review a review of complaints related to p/n 210080, lot 201843042205 shows 02 additional complaint(s) related to the failure in this investigation, pr #(b)(4).Conclusion: the failure mode has been confirmed via visual inspection.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.No additional investigation or specific actions are required.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

Cpd alerted our jr rep about cracking and delamination of the black leg holder.There is concern for further cracking and possible patient/staff harm when in use.Would like to replace the part.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: 9663233
• MDR Text Key: 177553136
• Report Number: 3005985723-2020-00070
• 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: 02/04/2020
• 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: 201843042205
• 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