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 Tissue Damage (2104); No Patient Involvement (2645)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplement al report will be submitted when additional information becomes available.

Event Description

Was asked back to spd to grab the bar extension and the boot (both carbon fiber pieces) from the clean side of spd because a hospital associate was checking both items for cleanliness and got splinters from the boot and extension.The boot is visibly frayed at the distal end and the bar extension, the associate told me she got them also from the distal end.Spd manager has asked me to replace both of these so that future spd staff do not get injured due to splintering.Zero issues before, during, or immediately after a case so i am not treating this as a case issue.Case type: n/a spd staff got carbon fiber splinters.Was reported in their own facility.Spd manager asked that i simply get them replaced, the injury is very minor and has been addressed internally.No pictures taken of the damage to these pieces.

Manufacturer Narrative

Correction: type of reportable event reported event: was asked back to spd to grab the bar extension and the boot (both carbon fiber pieces) from the clean side of spd because a hospital associate was checking both items for cleanliness and got splinters from the boot and extension.The boot is visibly frayed at the distal end and the bar extension, the associate told me she got them also from the distal end.Spd manager has asked me to replace both of these so that future spd staff do not get injured due to splintering.Zero issues before, during, or immediately after a case so i am not treating this as a case issue.Case type: n/a spd staff got carbon fiber splinters.Was reported in their own facility.Spd manager asked that i simply get them replaced, the injury is very minor and has been addressed internally.No pictures taken of the damage to these pieces.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 25 devices were manufactured and accepted into final stock on (b)(6) 2017 with no reported discrepancies.Additionally 1 device was manufactured and accepted into final stock on (b)(6) 2017 with no reported discrepancies.Complaint history review a review of complaints related to p/n: 210080, lot number: 201643120901, shows no additional complaint(s) related to the failure in this investigation.Conclusion the failure mode has been confirmed via visual inspection.Per d03391, 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

Was asked back to spd to grab the bar extension and the boot (both carbon fiber pieces) from the clean side of spd because a hospital associate was checking both items for cleanliness and got splinters from the boot and extension.The boot is visibly frayed at the distal end and the bar extension, the associate told me she got them also from the distal end.Spd manager has asked me to replace both of these so that future spd staff do not get injured due to splintering.Zero issues before, during, or immediately after a case so i am not treating this as a case issue.Case type: n/a spd staff got carbon fiber splinters.Was reported in their own facility.Spd manager asked that i simply get them replaced, the injury is very minor and has been addressed internally.No pictures taken of the damage to these pieces.

• 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: 9696039
• MDR Text Key: 180783646
• Report Number: 3005985723-2020-00084
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201643120901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other