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.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9696039
• MDR Text Key: 180783646
• Report Number: 3005985723-2020-00084
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201643120901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/11/2020 Patient Sequence Number: 1