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

Model Number 204992

Device Problems Break (1069); Material Frayed (1262)

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

Event Date 03/05/2019

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

After burring the majority of the femur the doctor stopped and noted something on the burr.After inspection i believed it was part of the lining of the burr guard attachment.I explained to the doctor what i believed the issue was and our options.The cylindrical debri was removed from the burr and the registration tool used to check the length of the burr.Upon passing, and proceeding with burring; some more pieces started to come out as we worked toward finishing the tibia.Case type: pka.Patient involvement: potential for debris remanences even though it was irrigated and suctioned well.Patient harm: none immediate however debris could remain and cause issues down the road.Patient status: the patient was under anesthesia mid case.

Manufacturer Narrative

Reported event: after burring the majority of the femur the doctor stopped and noted something on the burr.After inspection i believed it was part of the lining of the burr guard attachment.I explained to the doctor what i believed the issue was and our options.The cylindrical debri was removed from the burr and the registration tool used to check the length of the burr.Upon passing, and proceeding with burring; some more pieces started to come out as we worked toward finishing the tibia.Case type: pka patient involvement: potential for debris remanences even though it was irrigated and suctioned well.Patient harm: none immediate however debris could remain and cause issues down the road.Patient status: the patient was under anesthesia mid case.Product evaluation and results: as per the images provided in the communication log, the failure mode of some material falling out of the burr guard can be determined though the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 9 devices were manufactured and accepted into final stock on 01/02/2018.No non-conformances were identified during inspection.Review of the device history records indicate 72 devices were manufactured and accepted into final stock on 12/06/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204992, lot 40m037990 shows no additional complaint(s) related to the failure in this investigation.Conclusions: the failure could be determined via the image provided in the communication log but the product was not available for 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 associated with the product and failure mode reported in this event.

Event Description

After burring the majority of the femur the doctor stopped and noted something on the burr.After inspection i believed it was part of the lining of the burr guard attachment.I explained to the doctor what i believed the issue was and our options.The cylindrical debri was removed from the burr and the registration tool used to check the length of the burr.Upon passing, and proceeding with burring; some more pieces started to come out as we worked toward finishing the tibia.Case type: pka patient involvement: potential for debris remanences even though it was irrigated and suctioned well.Patient harm: none immediate however debris could remain and cause issues down the road.Patient status: the patient was under anesthesia mid case.

• Brand Name: BURR GUARD ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8425566
• MDR Text Key: 139205625
• Report Number: 3005985723-2019-00232
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486021856
• UDI-Public: 00848486021856
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204992
• Device Catalogue Number: 204992
• Device Lot Number: 40M037990
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization